FDA places clinical hold on trial of CAR-T for advanced myeloma after patient death
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The FDA placed a clinical hold on a clinical program designed to investigate a chimeric antigen receptor T-cell therapy for treatment of relapsed or refractory multiple myeloma following a patient death.
The hold applies to IMMagine-1, a multicenter phase 2 trial evaluating the investigational therapy CART-ddBCMA (Arcellx Inc.).
Arcellx officials believe “limitations on bridging therapy” are a contributing factor to the patient death, according to a company-issued press release.
The company is working with the FDA to amend protocols for the clinical program. The FDA also has cleared Arcellx to continue to dose patients who have undergone lymphodepletion.
"The safety and well-being of patients enrolled in our studies is our top priority,” Rami Elghandour,chairman and CEO of Arcellx, said in the release. “In coordination with our investigators, data safety monitoring board and our partners at Kite Pharma, we are working with FDA to address the clinical hold. The expansion of bridging therapy regimens is consistent with what's currently available in clinical practice and is in the best interest of patients.
“Additionally, we continue to evaluate other potential improvements to the study,” Elghandour added. “We remain confident that CART-ddBCMA is a potential best-in-class therapy for the treatment of patients with [relapsed or refractory multiple myeloma] based on the clinical profile observed in the patients dosed to date across our studies.”
CART-ddBCMA is an autologous, gene-edited CAR T-cell therapy that targets the B-cell maturation antigen (BCMA) on the surface of cancer cells.
The agent uses a novel synthetic binding domain to target BCMA, instead of animal-derived or humanized binders. This approach allows CART-ddBCMA to avoid provoking a host immune response that would blunt the effectiveness of the therapy once infused into a patient.
Last week, Seattle Children’s Hospital paused a phase 1 trial of an investigational CAR T-cell therapy for children or young adults with advanced CD33-positive acute myeloid leukemia after one person treated with the agent died.
That trial is evaluating SC-DARIC33, a CD33-directed, pharmacologically controlled CAR T-cell therapy being developed through a commercial collaboration with 2seventy bio.
The cause of death for that patient, as well as any potential relationship to the study regimen, are under investigation.
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