In June 2023, a patient death led the US Food and Drug Administration (FDA) to pause the iMMagine-1 study, putting a clinical hold on the chimeric antigen receptor (CAR) T-cell product CART-ddBCMA. In this video, Shambavi Richard, MD, of the Ichan School of Medicine, discusses what the clinical hold means for patients with relapsed or refractory multiple myeloma.
“I would say that this decision by the FDA is reflective of our current understanding and knowledge that we have been gaining on improving safety and reducing risks of CAR-T therapy,” Dr. Richard said. “It appears that the bridging therapy has been deemed to have contributed to the patient outcome in some way, either toxicity from the bridging itself or inadequacy of bridging therapy to accomplish its purpose, which is controlling the disease enough to manage the risks of [cytokine release syndrome], neurotoxicity, etc.”