The US Food and Drug Administration (FDA) has put a clinical hold on the investigational new drug CART-ddBCMA for the treatment of patients with relapsed or refractory multiple myeloma.
The clinical hold was received on June 16 following the recent death of a patient. Arcellx, the manufacturer of CART-ddBCMA, said in a press statement that the company believes that “limitations on bridging therapy are a contributing factor.” Arcellx reported that it is working with the FDA to amend the protocol to expand options for patients that are consistent with current clinical practice. The company also reported that the FDA provided clearance to Arcellx to continue to dose patients who have undergone lymphodepletion.
CART-ddBCMA is under evaluation in the phase II iMMagine-1 study, a pivotal, open-label, multicenter clinical trial. The primary objective of the study is to evaluate the overall response rate over a 24-month period. In addition to safety, secondary endpoints include depth of disease response, duration of response, and overall survival over a 24-month period.
Source: PR Newswire, June 2023