Arcellx announced this week that the U.S. FDA removed the partial clinical hold on the company's experimental drug CART-ddBCMA for the treatment of relapsed or refractory multiple myeloma, a rare type of blood cancer.
This decision followed collaborative efforts with the FDA, involving protocol updates, improved risk management strategies, and retraining of clinical sites. This allowed the approval of dosing for previously enrolled but untreated patients, preventing disruptions in treatment.
Back in June, Arcellx revealed that the FDA had placed a clinical hold on a trial for CART-ddBCMA, an innovative type of therapy that modifies a patient's immune cells to target and combat cancer cells, following the death of a patient. The trial, MMagine-1, is a phase 2 trial assessing CART-ddBCMA’s effectiveness in adults who were experiencing relapsed or refractory multiple myeloma. The study sought to measure the overall response rate over a 24-month timeframe with secondary endpoints such as evaluating the depth of disease response, response duration, and overall survival.
The patient's death was found to be related to cytokine release syndrome (CRS), a known side effect that is associated with CAR-T therapies. According to the company, the patient might have not received sufficient treatment for CRS.
CART-ddBCMA has received several designations from the FDA, including Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations. Multiple myeloma, a type of hematological cancer characterized by the accumulation of abnormal plasma cells in the bone marrow, leads to complications related to bones and a compromised immune system.