FT516 was engineered with a novel high-affinity, noncleavable CD16 Fc receptor, which is designed to maximize antibody-dependent cellular cytotoxicity by which NK cells recognize, bind, and eliminate antibody-coated cancer cells. FT596 comprises the hnCD16 Fc receptor and a CAR that targets CD19, which was designed to allow for the multiantigen targeting of cancer cells, and an interleukin (IL)-15 receptor fusion that strengthens the activity and survival of NK cells.
We are pleased with the interim safety, response rates, and durability of responses observed in our ongoing clinical studies of FT516 and FT596 for the treatment of patients with relapsed/refractory B-cell lymphomas, Scott Wolchko, president and chief executive officer of Fate Therapeutics, stated in a press release. These data continue to demonstrate that our off-the-shelf, iPSC-derived NK cell product candidates can uniquely deliver substantial therapeutic benefit and expand patient access to cell-based cancer immunotherapies.
In an ongoing phase 1 study (NCT04245722), FT596 is under investigation as a single-dose monotherapy and in combination with a single 375-mg/m2 dose of rituximab (Rituxan) in patients with relapsed/refractory B-cell lymphoma. Treatment was given 3 days following conditioning chemotherapy comprised of 500 mg/m2 of cyclophosphamide and 30 mg/m2 of fludarabine.
At a data cutoff of June 25, 2021, a total of 10 patients in the monotherapy arm and 10 patients in the combination arm were determined to be evaluable for assessment of safety and efficacy in the first cohort of 30 million cells (n = 3 each), second cohort of 90 million cells (n = 4 each), and third cohort of 300 million cells (n = 3 each).
Participants previously received a median of 4 lines of therapy, with a median of 2.5 lines of therapy that comprised CD20-targeted therapy. Of the 20 evaluable patients, 60% had aggressive B-cell lymphoma, half (50%) were refractory to the most recent therapy they received, and 35% of patients had prior autologous CD19-targeted CAR T-cell therapy.
In the second and third cohorts of patients who received FT596 as a single agent (n = 14), 71% achieved an objective response with the agent; this included a 50% complete response (CR) rate per PET-CT scan and Lugano 2014 criteria on day 29. Notably, 80% of patients who had not received prior CD19-targeted CAR T-cell therapy (n = 10) responded to FT596; the CR rate in these patients was 50%.
Additionally, half of 4 patients who had prior CD19-targeted CAR T-cell therapy achieved a CR, and both patients had received treatment on the combination arm.
In the first cohorts of both the monotherapy and combination arms (n = 6), only 1 patient experienced an objective response with FT596, which was indicative of dose-response treatment effects for the product.
The FT596-containing regimens were found to be well tolerated with no dose-limiting toxicities (DLTs) experienced, and no reported any-grade treatment-emergent immune effector cellassociated neurotoxicity syndrome (ICANS) or graft-versus-host disease. However, 2 cases of cytokine release syndrome (CRS) were observed; 1 of the cases was grade 1 and the other was grade 2. Both cases occurred concurrently with other cofounding clinical events and resolved on the same day of onset.
The dose-escalation study of the product is ongoing, and patients are currently being enrolled to the fourth single-dose cohort of 900 million cells in each arm.
The phase 1 FT516-101 trial (NCT04023071) enrolled patients with histologically documented B-cell lymphoma that was expected to have CD20 expression.2 Patients had to have relapsed/refractory disease following at least 1 previous systemic chemoimmunotherapy for which no available therapy was expected to produce a survival benefit. Moreover, patients needed to have measurable disease per Lugano classification and have previously undergone hematopoietic stem cell transplantation. Previous treatment with CAR T-cell therapies was allowed.
Participants received a regimen of 3 days of conditioning chemotherapy comprised of 500 mg/m2 of cyclophosphamide and 30 mg/m2 of fludarabine, a single dose of rituximab at 375 mg/m2, and 3 weekly doses of FT516, which were each given with IL-2 cytokine support; this was given for 2 cycles. The investigative regimen was designed to be given in the outpatient setting.
The primary objective of the research was to identify DLTs and to determine the maximum-tolerated dose and maximum-assessed dose of FT516. Other areas of interest included evaluating the safety, tolerability, preliminary activity, pharmacokinetics, and immunogenicity of the FT516-containing regimens.
A total of 13 patients had been included on the trial and received FT516 and rituximab. The median age of these patients was 65 years (range, 28-75), with 46.2% of patients under 65 years and 53.8% of patients 65 years of age or older. Moreover, 61.5% of patients were female, 46.2% had a diffuse large B-cell lymphoma histology, 76.9% had stage IV disease at the time of study entry, and 69.2% had bulky disease. Additionally, the median number of prior regimens received was 3 (range, 1-7), with a median of 2 (range, 1-6) prior anti-CD20 regimens received. Just under half, or 46.2%, of patients were refractory, 7.7% had previously undergone transplant, and 38.5% had previously received CD19-targeted CAR T-cell therapy.
A total of 11 patients received the regimen in the second and third multi-dose cohorts of 90 million cells per dose (n = 4) and 300 million cells per dose (n = 7).
Results presented during the 2021 ASCO Annual Meeting showed that 8 of these 11 patients who received the regimen at a dose of 90 million cells or higher achieved an objective response rate (ORR) of 73% with the treatment; this included 4 of 5 patients who were refractory to their last regimen received. Moreover, 6 patients (55%) achieved a CR to treatment on day 29 following the second FT516 treatment cycle; notably, this included 2 patients (50%) who had experienced disease progression after previous autologous CAR T-cell therapy.
Notably, at 3 months after the first infusion of the regimen, all 8 responders maintained their response without requiring further therapeutic intervention.
As of a data cutoff date of July 7, 2021, 45% maintained their response without the need for additional therapeutic intervention; 4 of these patients continued to experience a CR, ranging from 4.6 months to 9.5 months, and 1 patient remained in partial response, at 6.1 months. Two patients who had experienced a CR went on to experience disease progression, and 1 patient who had achieve a PR with the regimen required additional anticancer treatment.
Notably, no DLTs were observed with the regimen and no serious or grade 3 or higher adverse effects associated with FT516 were reported. As such, the FT516 was well tolerated. No treatment-emergent CRS, ICANS, or GVHD was observed.
Dose escalation is currently ongoing in the fourth multi-dose cohort of 900 million cells per dose.
At this time, we are initiating multiple indication-specific, dose-expansion cohorts to broadly assess FT516 in combination with CD20-targeted monoclonal antibody regimens, including in patients who have experienced disease progression following autologous CD19-targeted CAR T-cell therapy, Wolchko added in the release.
See the original post here:
Off-the-Shelf NK Cell Products FT596 and FT516 Show Early Promise in B-cell Lymphoma - OncLive
- Charles River Extends Gene Therapy Alliance with NUS Medicine - Contract Pharma - March 22nd, 2024
- Exciting opportunities in stem cell technology and regenerative biology in Indian healthcare industry - Express Healthcare - March 22nd, 2024
- Charles River Announces Extension of Gene Therapy Manufacturing Alliance with NUS Yong Loo Lin School of Medicine - Yahoo Finance - March 22nd, 2024
- Opinion: The revolutionary sickle cell therapies - MSN - March 22nd, 2024
- 10 Years of Kansas Regenerative Medicine Center - KSAL - March 22nd, 2024
- BioCardia and StemCardia Announce Biotherapeutic Delivery Partnership - Diagnostic and Interventional Cardiology - March 17th, 2024
- Cynata Therapeutics' breakthrough in regenerative medicine - Finance News Network - March 17th, 2024
- New Positive Data Presented on Briquilimab Conditioning in Patients with Fanconi Anemia - GlobeNewswire - March 17th, 2024
- Novel 3D stem cell therapy to treat critical limb ischaemia - Drug Target Review - March 15th, 2024
- Breaking Boundaries: Pharmicell's Bold Vision for Healthcare Transformation and Monumental Growth - The Worldfolio - March 15th, 2024
- CuSTOM Organoid Research Evolving From Tool to Treatment - Research Horizons - Research Horizons - March 15th, 2024
- BioCardia and StemCardia Announce Partnership to Deliver Cell-Gene Therapy for Remuscularization of Heart - Cath Lab Digest - March 15th, 2024
- Calidi Biotherapeutics and City of Hope Announce Funding from the California Institute for Regenerative Medicine ... - Business Wire - March 13th, 2024
- Iron restriction keeps blood stem cells young, researchers find - Phys.org - March 13th, 2024
- Vitamin A could have a key role in both stem cell biology and wound healing: Study - Medical Dialogues - March 9th, 2024
- Trends in Stem Cell Transplantation Refusal for Myeloma Treatment - Targeted Oncology - March 7th, 2024
- Stem Cell Therapy Market (CAGR) of 31.1%, Future of Market Size Emerging Technologies and their Impact on ... - Taiwan News - March 7th, 2024
- This Swedish startup wants to reduce the cost, and controversy, around stem cell production - TechCrunch - March 6th, 2024
- Advancing stem cell therapy: The regulatory process to get to clinical trials - The Economic Times - March 6th, 2024
- Transitioning from traditional surgical methods to the innovative use of stem cells - pharmaphorum - March 6th, 2024
- 'Mini organs' are grown from human stem cells taken during the late stages of pregnancy for the first time - m - Daily Mail - March 6th, 2024
- Stem cell transplant cures man of HIV and leukemia, one of five to achieve full remission - Fox 28 - March 3rd, 2024
- Stem Cell Therapy Market to Boost USD 137.5 Billion by 2034 and Projected to grow at 32.10% CAGR with increasing ... - Yahoo Finance - March 1st, 2024
- Studies expand use of stem cell therapies - WPLG Local 10 - March 1st, 2024
- Innovative therapy targets and destroys leukemia stem cells - News-Medical.Net - February 27th, 2024
- Unlocking the Potential of Stem Cells: The Medical Revolution of the Century - EIN News - February 27th, 2024
- Pelage Pharmaceuticals Announces $16.75M Series A Financing led by GV to Revolutionize Regenerative Medicine ... - Yahoo Finance - February 27th, 2024
- Say Her Name - Henrietta Lacks, The Real Mother Of Stem - Her Campus - February 27th, 2024
- California Man Free of HIV And Cancer in Astonishing Medical Recovery - ScienceAlert - February 25th, 2024
- $93 million for research into improved health for children, young people and the aged, medical devices, mental health ... - Department of Health - February 25th, 2024
- Stem Cells in Regenerative Medicine - PMC - National Center for ... - February 24th, 2024
- The Promise and Reality of Stem Cell Therapy: What You Need to Know - Corporate Wellness Magazine - February 22nd, 2024
- Stem Cell Therapy: A Beacon of Hope for Patients with Untreatable Conditions - Corporate Wellness Magazine - February 22nd, 2024
- Leading Experts in Stem Cell Therapy: A Global Overview - Corporate Wellness Magazine - February 22nd, 2024
- Can Stem Cells Help Reverse the Effects of Aging? - Corporate Wellness Magazine - February 22nd, 2024
- Stem Cell Therapy for Cancer: Hope on the Horizon? - Corporate Wellness Magazine - February 22nd, 2024
- Stem Cells and Autism: A Closer Look at Innovative Treatments - Corporate Wellness Magazine - February 22nd, 2024
- Regrowth and Restoration: The Science Behind Stem Cell Therapy for Hair - Corporate Wellness Magazine - February 22nd, 2024
- Brain Recovery: The Role of Stem Cells in Stroke and Cerebral Palsy Treatments - Corporate Wellness Magazine - February 22nd, 2024
- Turning Back the Clock: The Science of Stem Cells in Anti-Aging - Corporate Wellness Magazine - February 22nd, 2024
- Insights into cellular therapies for cancer treatment - Drug Target Review - February 22nd, 2024
- The Role of Stem Cells in Rheumatoid Arthritis Recovery - Corporate Wellness Magazine - February 22nd, 2024
- Dr Ernesto Romeros vision transforms immunotherapy regenerative medicine into a global leader in stem cell treatment - Khaleej Times - February 22nd, 2024
- World-Renowned Doctors Leading the Way in Stem Cell Research and Treatment - Medical Tourism Magazine - February 20th, 2024
- Choosing the Best: A Guide to America's Premier Stem Cell Therapy Providers - Medical Tourism Magazine - February 20th, 2024
- Navigating Through the Possibilities of Stem Cell Treatment for Eye Disorders - Medical Tourism Magazine - February 20th, 2024
- Global Leaders in Stem Cell Therapy: Where Excellence Meets Innovation - Medical Tourism Magazine - February 20th, 2024
- Excellence in Stem Cell Treatment: How the US is Pioneering Global Healthcare Solutions - Medical Tourism Magazine - February 20th, 2024
- Clarifying Memory Loss Treatments: The Role of Stem Cells - Medical Tourism Magazine - February 20th, 2024
- Battling Inflammation: Stem Cell Therapy for Rheumatoid Arthritis - Medical Tourism Magazine - February 20th, 2024
- Digestive Health and Stem Cells: Treating Ulcerative Colitis and Crohn's Disease - Medical Tourism Magazine - February 20th, 2024
- Top Stem Cell Clinics in the USA: Pioneering Treatments for Chronic Conditions - Medical Tourism Magazine - February 20th, 2024
- Stem Cells and Autism: Understanding the Potential for Innovative Treatments - Medical Tourism Magazine - February 20th, 2024
- Stopping the awakening of sleeping Acute Myeloid Leukaemia stem cells to prevent disease relapse - University of Birmingham - February 20th, 2024
- City of Hope Achieves Ground Breaking Treatment for Blood Cancer and HIV - Medriva - February 18th, 2024
- Regenerative Medicine Market Size to Worth USD 95 Billion by 2032 - InvestorsObserver - February 18th, 2024
- North America Organoids Market Projected to Reach US$ 5.35 Billion by 2030, Riding on a CAGR of 21.5% - GlobeNewswire - February 18th, 2024
- Chinese team tests lung treatment that may be first to reverse COPD damage - South China Morning Post - February 15th, 2024
- Why leukemic stem cells not harmed by chemotherapy begin to grow and produce AML cells after treatment - Medical Xpress - February 15th, 2024
- Regenerative Medicine Market is Expected to Reach $49.0 Billion | MarketsandMarkets - Yahoo Finance - February 15th, 2024
- Study finds interleukin-24 enhances CAR-T cell therapy's effectiveness against cancer stem cells - News-Medical.Net - February 15th, 2024
- Oldest Patient 'Cured' of HIV Still in Remission 5 Years After Transplant for AML - Medpage Today - February 15th, 2024
- Drug used for cocaine addiction may pave way for new treatment of advanced colon cancer - EurekAlert - February 15th, 2024
- Hematopoietic Stem Cells and Their Role in Development and Disease Therapy - The Scientist - February 15th, 2024
- Biomedical Researcher Seeks to Improve Outcomes in Stem Cell Treatments - University of Arkansas Newswire - February 13th, 2024
- Top 3 grants in regenerative medicine: January 2024 - RegMedNet - February 13th, 2024
- Scalise returning to Washington next week with cancer in complete remission - The Hill - February 13th, 2024
- Unlocking the power of stem cell therapy - Drug Target Review - February 9th, 2024
- Digging into the Dangers of Gene Therapy - The Medicine Maker - February 7th, 2024
- Treating and preventing abnormal heart beats with stem cell muscle grafts - Medical Xpress - February 7th, 2024
- Regeneration of the Retina Using Pluripotent Stem Cells: A Comprehensive Review - Cureus - February 3rd, 2024
- I thought I'll give it a chance - Liam Harrison reveals his thought process in getting crucial stem cell treatment - Sportskeeda - February 3rd, 2024
- Jennifer J. Raab named President and CEO of The New York Stem Cell Foundation - EurekAlert - February 3rd, 2024
- High-dose chemotherapy and autologous haematopoietic stem-cell transplantation in older, fit patients with primary ... - The Lancet - January 31st, 2024
- Houston regenerative medicine company to IPO, move toward more human trials - InnovationMap - January 31st, 2024
- New study on promising stem cell-based therapy for Crohn's disease - Medical Xpress - January 31st, 2024
- Exploring pharmacological, non-pharmacological, and stem cell therapies for treatment of autism spectrum disorders - News-Medical.Net - January 29th, 2024
- Stem cell study shows how gene activity modulates the amount of immune cell production in mice - Medical Xpress - January 26th, 2024
- Regenerative Medicine Market Set to Surge with 25.36% CAGR, Projected to Reach US$122.381 Billion by 2028 - GlobeNewswire - January 26th, 2024
- Global Graft Versus Host Disease (GvHD) Treatment Market Forecast, 2028: High Treatment Costs and Infection Risks ... - GlobeNewswire - January 26th, 2024
Recent Comments