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
