Arcellx announced this week that the FDA has placed a clinical hold on its investigational new drug (IND), CART-ddBCMA, intended for treating patients with relapsed or refractory multiple myeloma, due to a patient death.
The drug, a type of treatment that involves modifying a patient's immune cells to target cancer cells, faced a setback when a patient with advanced cancer — plasma cell leukemia — died. According to a recent statement by the Maryland-based biotech, the patient experienced cytokine release syndrome (CRS), a known side effect of CAR-T therapies. Arcellx believes that the patient did not receive sufficient treatment for CRS.
The drug utilizes a novel BCMA-targeting binding domain and has received Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations from the FDA.The trial in question, MMagine-1, is a phase 2 trial assessing CART-ddBCMA, a BCMA-targeted CAR-modified T-cell therapy developed by Arcellx. Multiple myeloma is a hematological cancer characterized by the accumulation of abnormal plasma cells in the bone marrow, leading to bone-related complications and impaired immune function.
The study aims to evaluate the treatment's effectiveness in adult patients with relapsed or refractory multiple myeloma with the primary objective to measure the overall response rate over a 24-month period and secondary endpoints that include disease response depth, response duration, and overall survival.
Multiple myeloma is a hematological cancer characterized by the accumulation of abnormal plasma cells in the bone marrow, leading to bone-related complications and impaired immune function.
Apart from multiple myeloma, Arcellx is also advancing ARC-SparX, a dosable and controllable CAR-T therapy, for acute myeloid leukemia and myelodysplastic syndrome treatment.