Early results from a phase 2 trial (NCT03019640) showed that cord bloodderived natural killer (NK) immunotherapy plus high-dose chemotherapy and autologous stem cell transplant (ASCT) induced early antitumor response in B-cell non-Hodgkin lymphoma (NHL).

The trial investigators evaluated the potential of the novel cellular cord bloodderived NK immunotherapy in patients with B-cell NHL who are undergoing high-dose chemotherapy and ASCT and presented their findings in a poster at the recent 2021 Transplant & Cellular Therapy Meetings. They chose CB units for NK cell expansion on artificial antigen presenting cells and without human leukocyte antigens (HLA) matching to provide increased expansion and make the treatment off-the-shelf capable.

The study enrolled patients who were aged 15 to 70 with B-cell NHL, excluding primary central nervous system lymphoma, who were candidates for high-dose chemotherapy and ASCT. Patients were required to have adequate end-organ function, an ECOG performance status of 0 or 1, and prior apheresis of 2 x 106 CD34+ cells/Kg in order to be eligible.

Those with prior whole brain irradiation, active hepatitis B, evidence of cirrhosis or high-grade liver fibrosis, active infection, HIV infection, or received radiation therapy within the past month were excluded from joining the trial.

Patients were given intravenous (IV) carmustine over 2 hours 12 days prior to transplant, IV etoposide twice daily over 3 hours and IV cytarabine twice daily over 1 hour for days 11 to 8 prior to transplant, IV melphalan over 30 minutes 7 days prior to transplant, oral lenalidomide (Revlimid) once daily for days 7 through 2 prior to transplant. Additionally, patients who are CD20-positive received IV rituximab (Rituxan) over 3 hours for days 13 through 7 prior to transplant.

Then patients received cord bloodderived expanded allogeneic NK cells intravenously over 1 hour on day 5 prior to ASCT. Five days following ASCT, patients started received daily subcutaneous filgrastim.

The primary end point was 30-day treatment-related mortality (TRM) and secondary end points were relapse-free survival (RFS), overall survival, and NK cell persistence.

Study authors, led by Yago L. Nieto, MD, PhD, in the Department of Stem Cell Transplantation, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center in Houston, provided an update on data for 20 of the enrolled patients in the study. Patients were enrolled between December 2017 and July 2020. One patient experienced rapid tumor progression during culture of NK cells and thus was not treated in the study.

The median age of the 19 treated patients was 60 years (range, 33-70) with the majority (73.7%) being male and having diffuse large B-cell lymphoma (DLBCL; 84.2%); the 3 remaining patients had mantle cell lymphoma (n = 2) or follicular lymphoma (n = 1). More than two-thirds (68.4%) of patients had relapsed disease whereas the 2 patients with MCL were being treated in the frontline setting and 4 patients had primary refractory disease. The median number of prior lines of therapy was 2 (range, 1-4).

Response assessed through PET at ASCT was a complete response for 78.9%, partial response for 15.8%, and progressive disease for 5.3%. Nine patients had 1/6 HLA match of cord blood at DR, 6 had 1/6 match at B, 3 had 1/6 match at A, and 1 had 2/6 match at B and DR.

Cord bloodderived NK cells were expanded a median of 1552-fold (range, 317-4767) with the infused NK product comprising a CD3-CD16+CD56+ phenotype for a median of 98.9% (range, 97.6%-99.5%) of the cells. The cord bloodderived NK cells had a median viability of 96.5% (range, 92%-98%). In the peripheral blood, NK cells were detectable for a mean of 2 weeks (range, 2-3).

For weeks 1 through 3, the cord bloodderived NK cells showed a higher percentage of NKG2D and NKp30 activation receptors than the patients own NK cells; the study authors noted that this indicated an effector phenotype. Additionally, NK persistence was found not to be impacted by the degree of HLA mismatch.

At a median follow-up of 18 months (range, 4-340), the RFS rate was 68% and the OS rate was 84%. Eleven of the 16 patients (68.8%) with DLBCL are still in remission.

The study authors concluded that expanded and highly purified cord bloodderived NK immunotherapy was safe and promising in combination with high-dose chemotherapy and ASCT in patients with B-cell NHL.

Reference:

Nato Y, Kaur I, Hosing C, et al. Immunotherapy with ex vivo-expanded cord blood (CB)-derived nk cells combined with high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT) for B-cell non-hodgkins lymphoma (NHL). Presented at: 2021 Transplant & Cellular Therapy Meetings; February 8-12, 2021; Virtual. LBA15.

See the original post here:
In B-Cell NHL, Off-the-Shelf NK Immunotherapy Shows Promise When Used With Chemotherapy and ASCT - Cancer Network

SILVER SPRING, Md., Feb. 8, 2021 /PRNewswire/ -- The following quote is attributed to Steven M. Solomon, D.V.M., M.P.H., director of the FDA's Center for Veterinary Medicine:

Veterinary regenerative medicine is a rapidly growing area of product development that offers great promise in the development of novel therapies for animals. These products, which include animal cell-based therapies such as stem cells, have the potential to repair diseased or damaged tissues in animals through regeneration and healing.

Today, the U.S. Food and Drug Administration is announcing a listing of clinical field studies that are investigating Animal Cells, Tissues, and Cell- and Tissue-Based Products (ACTPs) in veterinary patients. The webpage provides animal owners, veterinarians, researchers and the public with information on clinical field studies that are being investigated for the use of ACTPs in veterinary patients.

We are offering this webpage as a resource because we've heard from veterinarians and pet owners who are eager to take part in clinical studies and avail their patients and pets of the potential that veterinary regenerative medicine may offer. Connecting interested pet owners and their veterinary teams with relevant clinical studies also helps sponsors in generating data toward potential FDA approval.

Generally, the FDA regulates ACTPs as animal drugs if they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease (e.g., osteoarthritis and tendon injuries in animals) in animals, or intended to affect the structure or any function of the body (e.g., improving animal fertility) of animals. The FDA's Center for Veterinary Medicine provides regulatory oversight of clinical field studies for ACTPs, provides veterinary medical researchers with information to address scientific challenges and provides guidance on the regulatory process for their products. We also offer the Veterinary Innovation Program (VIP) to certain sponsors of ACTPs, which helps facilitate advancements in the development of innovative animal products by encouraging development and research, and supporting an efficient and predictable pathway to approval for these products.

Clinical field study information on the webpage includes study name, species, condition, product type, recruitment period, study period, country or state and phone number and/or email address of the sponsor. Clinical field studies evaluating ACTPs are listed on the webpage when the sponsor has provided specific information to the FDA about the study and the sponsor consents to having their study information listed on the webpage. At the time of listing, the information is intended to disclose clinical field studies in support of product development and FDA approval.

Participation is voluntary in clinical field studies for investigational ACTPs, and sponsors must voluntarily consent to having the FDA list their study information on the webpage. The studies listed on the webpage are investigational, and the ACTPs are not FDA-approved. This means the safety and effectiveness of the ACTP is not yet determined. The webpage will be updated with new clinical studies on a quarterly basis, and we expect the list of studies to grow.

We welcome the opportunity to continue working with ACTP sponsors to discuss innovative approaches in developing treatments needed to support safe and effective animal therapies. Our ultimate objective is to obtain interpretable data from well-conducted, well-designed scientific studies. We look forward to working withindividuals, universities and drug companieswho develop this information and to gain a fuller understanding of the potential benefits and risks associated with ACTPs.

As scientists continue to research new and innovative therapies for animal health using animal cells and tissue, we encourage sponsors to develop the data needed to seek potential FDA-approval for their ACTPs. At the same time, we remain committed to taking action as necessary to protect public health against companies that illegally market ACTPs.

Sponsors of ACTPs that are interested in having their clinical trials listed on the FDA's webpage can contact their FDA project manager.

Additional Resources:

Media Contact:Monique Richards, 240-402-3014Veterinary and Consumer Inquiries: [emailprotected]or 800-835-4709

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration

http://www.fda.gov

See the original post here:
FDA Announces New Resource for Veterinarians and Pet ...

Early antitumor activity was seen with cord bloodderived natural killer (NK) immunotherapy in combination with high-dose chemotherapy and autologous stem cell transplant (ASCT) in patients with B-cell non-Hodgkin lymphoma (NHL), according to early results from a phase 2 trial (NCT03019640) presented in a poster during the 2021 Transplant & Cellular Therapy Meetings.

The investigators evaluated the potential of the novel cellular cord bloodderived NK immunotherapy in patients with B-cell NHL who are undergoing high-dose chemotherapy and ASCT. They chose CB units for NK cell expansion on artificial antigen presenting cells and without human leukocyte antigens (HLA) matching to provide increased expansion and make the treatment off-the-shelf capable.

The study enrolled patients who were aged 15 to 70 with B-cell NHL, excluding primary central nervous system lymphoma, who were candidates for high-dose chemotherapy and ASCT. Patients were required to have adequate end-organ function, an ECOG performance status of 0 or 1, and prior apheresis of 2 x 106 CD34+ cells/Kg in order to be eligible.

Those with prior whole brain irradiation, active hepatitis B, evidence of cirrhosis or high-grade liver fibrosis, active infection, HIV infection, or received radiation therapy within the past month were excluded from joining the trial.

Patients were given intravenous (IV) carmustine over 2 hours 12 days prior to transplant, IV etoposide twice daily over 3 hours and IV cytarabine twice daily over 1 hour for days 11 to 8 prior to transplant, IV melphalan over 30 minutes 7 days prior to transplant, oral lenalidomide (Revlimid) once daily for days 7 through 2 prior to transplant. Additionally, patients who are CD20-positive received IV rituximab (Rituxan) over 3 hours for days 13 through 7 prior to transplant.

Then patients received cord bloodderived expanded allogeneic NK cells intravenously over 1 hour on day 5 prior to ASCT. Five days following ASCT, patients started received daily subcutaneous filgrastim.

The primary end point was 30-day treatment-related mortality (TRM) and secondary end points were relapse-free survival (RFS), overall survival, and NK cell persistence.

Study authors, led by Yago L. Nieto, MD, PhD, in the Department of Stem Cell Transplantation, Division of Internal Medicine, The University of Texas MD Anderson Cancer Center in Houston, provided an update on data for 20 of the enrolled patients in the study. Patients were enrolled between December 2017 and July 2020. One patient experienced rapid tumor progression during culture of NK cells and thus was not treated in the study.

The median age of the 19 treated patients was 60 years (range, 33-70) with the majority (73.7%) being male and having diffuse large B-cell lymphoma (DLBCL; 84.2%); the 3 remaining patients had mantle cell lymphoma (n = 2) or follicular lymphoma (n = 1). More than two-thirds (68.4%) of patients had relapsed disease whereas the 2 patients with MCL were being treated in the frontline setting and 4 patients had primary refractory disease. The median number of prior lines of therapy was 2 (range, 1-4).

Response assessed through PET at ASCT was a complete response for 78.9%, partial response for 15.8%, and progressive disease for 5.3%. Nine patients had 1/6 HLA match of cord blood at DR, 6 had 1/6 match at B, 3 had 1/6 match at A, and 1 had 2/6 match at B and DR.

Cord bloodderived NK cells were expanded a median of 1552-fold (range, 317-4767) with the infused NK product comprising a CD3-CD16+CD56+ phenotype for a median of 98.9% (range, 97.6%-99.5%) of the cells. The cord bloodderived NK cells had a median viability of 96.5% (range, 92%-98%). In the peripheral blood, NK cells were detectable for a mean of 2 weeks (range, 2-3).

For weeks 1 through 3, the cord bloodderived NK cells showed a higher percentage of NKG2D and NKp30 activation receptors than the patients own NK cells; the study authors noted that this indicated an effector phenotype. Additionally, NK persistence was found not to be impacted by the degree of HLA mismatch.

At a median follow-up of 18 months (range, 4-340), the RFS rate was 68% and the OS rate was 84%. Eleven of the 16 patients (68.8%) with DLBCL are still in remission.

The study authors concluded that expanded and highly purified cord bloodderived NK immunotherapy was safe and promising in combination with high-dose chemotherapy and ASCT in patients with B-cell NHL.

Reference:

Nato Y, Kaur I, Hosing C, et al. Immunotherapy with ex vivo-expanded cord blood (CB)-derived nk cells combined with high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT) for B-cell non-hodgkins lymphoma (NHL). Presented at: 2021 Transplant & Cellular Therapy Meetings; February 8-12, 2021; Virtual. LBA15.

Read more from the original source:
Off-the-Shelf NK Immunotherapy Is Safe and Promising in B-Cell NHL With Chemotherapy and Transplant - Targeted Oncology

15 February 2021

MSc Bioethics and Society student, King's College London

The '14-day rule', initially proposed in 1979 in the USA, was first recommended in the UK by the Warnock Committee in 1984. It limits research on intact human embryos to 'prior to 14 days' gestation or the beginning of primitive streak formation' and is part of the Human Fertilisation and Embryology Act 2008.

This legislation has been successfully implemented in the UK, but also in several other countries (eg, Australia's Research Involving Human Embryos Act 2002). It is followed in jurisdictions without relevant laws or even guidelines. While researchers accepted the rule, and have been content to keep to it, many contend that it was simply an arbitrary time limit that was chosen as a compromise to authorise any research at a time when prolife views were strong. While originally it was a barrier that could not be breached for practical reasons, recent research on human and non-human primate embryos suggest that we now have methods to culture intact human embryos beyond 14 days.

I recently argued, in the Journal of Medical Ethics, that the current limit for embryo research should be extended to 28 days to permit research that will further explore our origins as well as potentially provide new therapeutic possibilities to reduce developmental abnormalities and miscarriage.

This conversation is something the Progress Educational Trust (PET), the charity which publishes BioNews, has been advocating for many years. Recent work they have accomplished includes a proposal to the 'My Science Inquiry' launched by the House of Commons Science and Technology Committee. Sandy Starr, deputy director of PET gave oral evidence to the committee advocating for this conversation to be had by government, as it is already an ongoing debate within the scientific community. PET also held their annual conference in 2016, which focused on the 14-day limit on human embryo research, and that featured Baroness Mary Warnock, who was chair of the committee that originally proposed the limit in 1984.

There are a number of reasons why research on embryos between 14 and 28 days, often referred to as the 'black box' period of development, is now ready to be initiated. Several of these are emphasised in my paper.

Firstly, the 'black box' period is when the basic body plan and the formation of critical cell types, tissues, and some organs is initiated. These include germ cells, which are not only essential for the next generation, but are also the early progenitors of the nervous system, blood cells and the heart, and the placenta. It is known that even a subtle defect can have a devastating effect on subsequent development. While we know something about how these develop in model organisms such as the mouse, there are clear differences with human embryos, making it difficult to infer results between species. We also can't yet rely on new stem cell-based models of early human embryos without first carrying out detailed comparisons with the real thing.

It could be argued that 28 days is not long enough. Whilst this is certainly a thought-provoking point, we are already able to obtain embryonic tissues from 28 days and beyond and older fetal tissue to use in scientific research eg, from an aborted fetus. It is also important to consider the need for a 'limit'. If there is not one at all, there is no compromise, discontent, and it could complicate the regulatory system.

In conversations surrounding the 14-day limit there are differing ethical opinions. I argue that in order for those trying for a baby to have legitimate reproductive autonomy, they should have the appropriate assistance and opportunity to produce, at the very least, a healthy child. I also focus on the need to differentiate between 'research' embryos and 'reproductive implanted embryos' ie, the research embryos in question are those whose location will remain in a petri dish.

It is absolutely crucial to outline the importance of a robust regulatory body. In the UK, we are lucky to have the Human Fertilisation and Embryology Authority (HFEA), which means there is government oversight making sure fertility clinics and research centres comply with the law, this extends to human embryo research. For example, in 2016, Dr Kathy Niakan was not just the first person in the UK to be granted a license from the HFEA to use genome editing techniques on human embryos, but the first anywhere to have this type of research sanctioned by a regulatory body. (See BioNews 835).

With any significant legislative change that will directly impact the population, significant public debate must be instigated. Public opinion must be widely surveyed and considered, because any decisions like this should not just be one made by a select few individuals. This can be seen with another significant change in the HFE Act, the addition of mitochondrial donation regulations in 2015, which is an example where public engagement was very important. It gave the Government license to make the changes in the Act, knowing that there was broad support for the use of the methods to avoid mitochondrial disease.

As I conclude in the paper, just because something has once worked does not mean it should stay the same or not strive to be improved. The 14-day limit has become limiting and the conversation around extension must continue.

Go here to read the rest:
The 14-day limit should be extended to 28 days - BioNews

The NCD for Allogeneic Hematopoietic Stem Cell Transplantation (allo HSCT) for the treatment of Myelodysplastic Syndromes (MDS), released by CMS in August 2010, concluded that, absent convincing evidence that allo HSCT improves patient health outcomes, additional research from clinical trials would be appropriate under the Coverage with Evidence Development aspect of CMS coverage authority. The NCD specifies that allo HSCT for the treatment of MDS is covered only when provided to Medicare beneficiaries enrolled in an approved clinical study

Allo HSCT is a procedure in which a portionof a healthy donor's stem cell or bone marrow is obtained and prepared for intravenous infusion. In accordance with the Stem Cell Therapeutic and Research Act of 2005 (US Public Law 109-129) a standard dataset is collected for all allogeneic transplant patients in the United States by the Center for International Blood and Marrow Transplant Research. The elements in this dataset, comprised of two mandatory forms plus one additional form, encompass the information we require for a study under CED.

A prospective clinical study seeking Medicare payment for treating a beneficiary with allogeneic HSCT for MDS pursuant to CED must meet one or more aspects of the following questions:

Potentially, the results of trials may provide sufficient evidence of clinical utility that a future NCD on this topic will provide coverage for such testing for all Medicare beneficiaries.

Decision Memo

Study Title: A Multi-Center Biologic Assignment Trial Comparing Allogeneic Hematopoietic Cell Transplant to Hypomethylating Therapy or Best Supportive Care in Patients w/Intermediate-2 & High Risk Myelodysplastic Syndrome (BMT CTN #1102)Sponsor: Medical College of WisconsinClinicalTrials.gov Number: NCT02016781CMS Approval Date: 12/11/2013

Study Title: Assessment of Allogeneic Hematopoietic Stem Cell Transplantation in Medicare Beneficiaries with Myelodysplastic Syndrome and Related Disorders" - A Sub-study Protocol For A Research Database For Hematopoietic Stem Cell Transplantation, Other Cellular Therapies and Marrow Toxic InjuriesSponsor: Center for International Blood and Marrow Transplant ResearchClincialTrials.gov Number: NCT01166009CMS Approval Date: 12/13/2010

See the original post here:
Allogeneic Hematopoietic Stem Cell Transplant for MDS | CMS

A post-hoc analysis of the practice-changing TRANSCEND NHL 001 trial (NCT02631044) revealed that exposure to anti-CD19 therapy in patients with relapsed/refractory large B-cell lymphoma (LBCL), did not impact response to lisocabtagene maraleucel (liso-cel; Breyanzi).1

Data were presented during the 2021 Transplantation & Cellular Therapy Meeting and showed that among 12 patients who had previously received anti-CD19 therapy, 2 patients achieved a complete response (CR) as their best response to that treatment, 3 patients reported a partial response (PR), and 1 achieved stable disease. Five patients experienced disease progression, while 1 patients response status was unknown.

Results from the analysis showed that 92% (n = 11/12) experienced an objective response to liso-cel per independent review committee (IRC) assessment and Lugano criteria; this included 6 CRs (50%) and 5 PRs with the CAR T-cell therapy. Moreover, 5 patients experienced a duration of response (DOR) to liso-cel of 9 months or longer (range, 0.8-27.4), with 4 patients continuing to respond at the time of data cutoff.

The response rates reported in this subgroup proved to be comparable to those observed in the overall TRANSCEND NHL 001 study population. Of the 256 patients determined to be efficacy evaluable, which included those who were given at least 1 dose of liso-cel and had PET-positive disease per IRC, the objective response rate was 73% (95% CI, 66.8%-78.0%), with a CR rate of 53% (95% CI, 46.8%-59.4%).2 The median DOR had not been reached (95% CI, 8.6not reached [NR]). Moreover, the median progression-free survival (PFS) was 6.8 months in this population (95% CI, 3.3-14.1) and the median overall survival (OS) was 21.1 months (95% CI, 13.3-NR).

In this post-hoc analysis of a small subset of patients from TRANSCEND, patient response to liso-cel and liso-cel pharmacokinetics were not impacted by prior exposure to anti-CD19 therapy, Scott R. Solomon, MD, of the Blood and Marrow Transplant Program, Leukemia and Cellular Immunotherapy Program at the Northside Hospital Cancer Institute, and colleagues, wrote in a poster highlighting the data. Additional analyses on a larger number of patients with prior anti-CD19 therapy are warranted to confirm these findings.

An investigational, CD19-targeted, defined composition, 4-1BB CAR T-cell product, liso-cel is given at equal target doses of CD8 and CD4 T cells; the product has showcased safety and efficacy in patients with aggressive, relapsed/refractory LBCL in the TRANSCEND NHL 001 trial. Data from the trial led to theFebruary 2021 FDA approval of liso-cel for use in adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least 2 other types of systemic treatment.

The multicenter, pivotal, phase 1 trial enrolled adult patients aged 18 years or older with relapsed/refractory LBCL; this included those with diffuse large B-cell lymphoma (DLBCL); high-grade B-cell lymphoma with rearrangements of MYC and either BCL-2, BCL-6, or both; DLBCL transformed from an indolent lymphoma; primary mediastinal B-cell lymphoma; and follicular lymphoma. To be eligible for enrollment, patients had to have an ECOG performance status of 0-2, creatinine clearance of greater than 30 mL/min/1.73 m2, and a left ventricular ejection fraction of at least 40%.

Those who underwent prior hematopoietic stem cell transplantation and those with secondary central nervous system lymphoma were permitted. Notably, no lower threshold for absolute lymphocyte count, absolute neutrophil count, platelets, or hemoglobin, were established.

In the trial, patients were screened and then underwent leukapheresis where bridging therapy was permitted while the product was being manufactured. Once disease was reconfirmed via PET imaging, patients went on to receive lymphodepleting chemotherapy with fludarabine at 30 mg/m2 and cytarabine at 300 mg/m2, delivered over the course of 3 days. Two to 7 days after the chemotherapy, patients received liso-cel.

A total of 269 participants were assigned to 1 of 3 target dose levels of the CAR T-cell product: 50 106 CAR T cells (1 or 2 doses), 100 106, and 150 106; this was given as a sequential infusion of 2 components, CD8 and CD4 CAR T cells, at equal target doses.

The co-primary end points of the trial included adverse effects (AEs), dose-limiting toxicities, and ORR per Lugano criteria and IRC. Key secondary end points comprised CR rate by IRC, DOR, PFS, OS, and cellular kinetics.

For the post-hoc analysis, investigators looked at a subset of patients from the trial who had previously received CD19-targeted therapy before liso-cel to evaluate impact of the CAR T-cell product on safety and efficacy outcomes, as well as cellular kinetics.

The median age of the 12 patients in the subgroup of interest was 60.5 years, and 83% were male. Half of the patients had an ECOG performance status of 0, while the remainder had a status of 1. The median number of previous lines of treatment was 4. Fifty-eight percent of patients previously underwent transplantation and 67% were refractory to chemotherapy. Regarding histology, 58% had DLBCL not otherwise specified, 33% had DLBCL that was transformed from follicular lymphoma, and 8% had high-grade B-cell lymphoma.

Additional data showed that previous anti-CD19 therapy did not impact cellular kinetic parameters. Liso-cel demonstrated long-term persistence at 3 months in the majority, or 83% (n = 5/6), of those who received prior CD19-targeted treatment; persistence at 1 year was observed in 50% of patients (n = 2/4), which was comparable to those who did not receive previous CD19-targeted treatment.

Regarding safety, all patients in this subgroup experienced treatment-emergent AEs (TEAEs), 58% (n = 7) of which were grade 3 or higher. The most reported grade 3 or higher TEAEs included neutropenia (58%), thrombocytopenia (42%), and anemia (33%). Sixty-seven percent of patients reported all-grade cytokine release syndrome (CRS) and 42% experienced all-grade neurological effects with liso-cel. However, all toxicity rates proved to be comparable to those experienced by the overall study population and all CRS or neurological effects were either grade 1 or 2.

These findings suggest that liso-cel can be considered for the treatment of patients who have received prior anti-CD19 therapies, concluded Solomon.

References:

1. Solomon S, Mehta A, Abramson JS, et al. Experience of prior anti-CD19 therapy in patients with relapsed or refractory large B-cell lymphoma receiving lisocabtagene maraleucel (liso-cel), an investigational anti-CD19 chimeric antigen receptor T cell product. Presented at: 2021 Transplantation & Cellular Therapy Meeting; February 9-13, 2021; Virtual.

2. Abramson JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020;396(10254):839-852. doi:10.1016/S0140-6736(20)31366-0

Read more here:
Responses to Liso-Cel Not Influenced by Prior Treatment With Anti-CD19 Agents in R/R Large B-Cell Lymphoma - Targeted Oncology

CLEVELAND, Ohio What do you do when someone close to you has cancer?

Sometimes, late at night, I just hug Otto and cry, said Shanna Loede.

Otto is not her husband. Thats Matt Loede, who has been in a battle with lymphoma (a form of blood cancer) for nearly two years.

There have been 25 rounds of chemotherapy. And 25 rounds of radiation. And two stem-cell transplants. And nearly three months spent in the hospital since Matt was first diagnosed in April of 2019.

As if that wasnt enough, Matt recently spent five days in the hospital with COVID-19.

Matt is Shannas husband of eight years. He also has worked for several local sports radio stations, written for a number of sports websites in his 23-year career. He currently writes for the sports website Outkick.

OK, but who is Otto?

Hes the familys mixed terrier, a very huggy dog.

Otto knows to stay close when the sadness and fear try to squeeze the life out of hope and the tears flow with her prayers for her husband.

One piece of advice from Shanna: Its OK to have some nights when you just cry. Having someone (or a pet to hug) really helps.

HOW MUCH WORSE CAN IT GET?

Matts problems began with severe stomach pain and convulsions. Doctors first thought he had pancreatitis. Tests revealed lymphoma that had spread to his stomach and pancreas. At first, the hope was some early treatments would bring it under control.

That turned out to be wrong.

You find out theres a lot you cant control about this type of cancer, said Matt. Its like a tumor in the blood. But its not something they can just go in and cut out.

The Loedes hit what they thought was a low point in early January. A second round of stem cell transplants didnt work. The cancer had spread to his throat.

It was a special treatment, said Shanna. I had read so much about it. There was so much hope. It sounded like the saving grace for lymphoma. I probably overestimated it.

Doctors explained they had run out of the usual treatments.

There is no cure for me, said Matt. I know that hit Shanna hard when she heard the news.

That was one of the worst days. A few weeks later, Matt developed a cough. Then he had a sore throat and headaches.

One of Shannas biggest fears was Id get the virus, he said.

She panicked when taking his temperature. It was 104.

They rushed to University Hospital, where he had been undergoing treatments at the Seidman Cancer Center. Only now, he was in the COVID-19 section of the hospital. It was isolation for five days.

The fever broke within a few hours. But given how Matts body had been ravaged by nearly two years of chemotherapy and radiation, Shanna feared I was going to lose him.

But that didnt happen.

He didnt even need a ventilator, said Shanna. Matt has recovered well. Thats one of the things I tell people in this situation. Count your blessing, look for the miracles.

Shanna is the Director of Training and Development for University Hospitals. In the COVID world, she works from her small upstairs office in their Parma home. Matt is downstairs.

Another blessing, she said. Seidman gives Matthew great care, and Im affiliated with UH. Working from home allows us to be together more.

Shanna and Matt Loede love each other and Snoopy as they work together to fight Matt's blood cancer. Photo by Terry Pluto, cleveland.com.

IT REALLY IS DAY-TO-DAY

Shanna said she is a planner. She is 38, Matt is 45. Under normal circumstances, it would be easy to look way down the highway of life.

I like to think a lot about the future, she explained. Now, it really is day-to-day. Matthew is the love of my life. I try not to think, How long will I have him? Instead, I try to focus on the present. Thats new for me.

The doctors have never told the Loedes Matt has six months to live. But they have been candid about how its a battle to combat the spread. He is now heading into different clinical trials.

Theres not much Shanna can do on the medical front other than be there for her husband.

I cook his favorite food, she said.

Whats that?

Asian meatballs and rice, she said. Matthew is a pretty simple guy. He does like his mothers pierogies, but I cant make them like her.

Shanna raves about her neighbors, who have shoveled snow and brought food over to the house. Their church family from Cleveland Baptist prays for and with them.

There is a couple at church where the husband has had lymphoma for eight years, she said. They are a great help to us...and weve found we can help others going through cancer.

During the Christmas season, you can see Matt and Shanna Loede have lots of visitors. Photo courtesy of Matt Loede.

STRANGE DREAMS

Dreams can be a window to our minds and our fears.

Shanna said twice she had this dream: Matt walks through the door and says, I have six months to live.

But she hasnt had it for a year.

A few times, Matt has dreamed he was watching is own funeral. He saw the casket. He saw lots of people in line to pay their last respects.

I guess it was after the pandemic with all the people there, he said with a laugh.

But Shanna and Matt both said, Going through this makes you very aware of your own mortality.

CLOSER OR FARTHER APART

Matt said he hasnt spent much time on the Why me? question with God. Theres no answer coming. Hes at a place where he knows he has cancer. He is either going through it with God or without God.

If you say you believe and your faith is real, then you have to practice what you preach, said Matt. You dont just quit (with God) when you go though those periods of 12-to-48 hours after chemo where your muscles, your head, everything aches.

Shanna said thats when she feels helpless. Its a time to pray and wait.

I have felt closer to God and to Matthew during all of this, she said.

Matt loves Charlie Brown. Their home is filled with stuffed characters from the Charles Schulz comic strip. Snoopy seems to be everywhere.

At first, (all the stuffed animals) drove me a little crazy, said Shanna. But now, Im accustomed to them. They bring him comfort, and Ill never argue against something bringing him happiness right now.

Good Grief, is Matt like Charlie Brown?

I never thought of until now, she said. But yes. He is loyal, has a BIG heart and is a resilient optimist.

Good Grief! Snoopy & Friends are taking over the Loede household. Photo courtesy of Matt Loede.

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Canine Stem Cell Therapy Market is Estimated to Perceive Exponential Growth till 2026 NeighborWebSJ - NeighborWebSJ

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AbbottSWP PharmaceuticalHandewei PharmaceuticalPfizerSaike PharmaceuticalSanjin PharmaceuticalJinrui Pharmaceutical

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StatinsBile Acid ResinsFibric Acid and Omega-3 Fatty Acid Derivatives

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Hospital PharmaciesRetail PharmaciesOnline Pharmacies

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Canine Stem Cell Therapy Industry Market 2021 Growth By Manufacturers, Type And Application, Forecast To 2027:Abbott, SWP Pharmaceutical, Handewei...

Regenerative therapies such as stem cells and platelet-rich plasma already play an important role in managing osteoarthritis (OA). Nonetheless, veterinarians have found that response to even these therapies is less than ideal in many cases, prompting researchers to continuously seek novel therapies for this all-too-common musculoskeletal disorder. One of the newest to be unveiled is called bone marrow mononuclear cell (BMNC) therapy. One researcher who presented at the 2020 American Association of Equine Practitioners Convention, held virtually, reported that the equine industry is in critical need for therapies that resolve joint inflammation but preserve tissue healing, and BMNC appears a promising candidate.

Much more than stem cells classically sought for cartilage healing, bone marrow is rich in macrophage progenitor cells, explained James B. Everett, DVM, MS, previously of the Virginia-Maryland College of Veterinary Medicine, who now works at the Equine Surgical Center at ThorSport Farm,in Murfreesboro, Tennessee. Macrophages are a type of white blood cell that play a role in tissue repair and cartilage integrity, and produce the anti-inflammatory mediators, including interleukin-10 (IL-10).

Everett said macrophages in the synovial (joint) membrane are essential for joint health, clearing aggressors, secreting key molecules required for optimal joint function, and forming a shield that protects tissues undergoing repair, similar to a wound scab. However, when the amount of tissue damage overwhelms these housekeeping functions, macrophages stimulate inflammation as a means of recruiting more cells, especially more macrophages, to cope with increased demands for repair.

If this response is efficiently accomplished, macrophages then produce, among other things, high concentrations of IL-10 and resolve the inflammatory process, returning the joint to a healthy state, he said.

Everett emphasized that not all inflammation is bad. This acute inflammation is essential to establish a resolving response, and anti-inflammatory therapies can negatively interfere.

As presented by Everetts colleague Bruno Menarim, DVM, PhD, in a separate session, studies show that BMNCs promote the endogenous resolution of experimentally induced inflammation. To see if these promising features translated to naturally occurring inflammation in live horses, Everetts research team studied 19 horses, dividing them into three treatment groups:

The selected horses were diagnosed with OA in a single joint, and the team injected those joints once with the saline, triamcinolone, or BMNCs. The BMNCs were autologous, meaning veterinarians collected them from each patients own bone marrow aspirate. They processed the aspirate in-house, and the isolated mononuclear cells, composed predominantly of macrophages, were ready to inject into the affected joint within three hours of aspiration.

We found that while objectively assessed lameness (via Lameness Locator) decreased in all three groups, it was only significant in the BMNC-treated horses, said Everett. Further, the treatment was well-tolerated with no adverse events appreciated in this study.

He said that using BMNCs can help reduce the need for chronic use of non-steroidal anti-inflammatory drugs and corticosteroids, which produces potentially harmful consequences. Further, BMNCs preserve the production of molecules such as interleukins and cytokines that are essential for restoring joint homeostasis. Corticosteroids often inhibit these molecules.

The researchers noted that these results support a larger clinical trial using BMNCs in clinical cases of equine OA.

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Novel Bone Marrow 'Ingredient' To Help Arthritic Horses The Horse - TheHorse.com