Clinical Hold on Cellectis CAR T Cell Therapy

FDA has placed a clinical hold on a Cellectis multiple myeloma trial (MELANI-01 study) after a study patient died. MELANI-01 is a Phase 1 dose escalation clinical study evaluating a gene-edited T-cell product candidate (UCARTCS1A) for treating patients with relapsed or refractory multiple myeloma, according to the company. It says the patient, who previously had been treated unsuccessfully with numerous lines of prior therapy, including autologous CAR T-cells, “experienced a fatal treatment-emergent adverse event of cardiac arrest. Clinical evaluation of the case remains ongoing and additional details as to the immediate and underlying causes of this event are being collected.” Patient enrollment is ongoing in two other Phase 1 dose escalation trials — AMELI-01 evaluating UCART123 in relapsed and refractory acute myeloid leukemia and BALLI-01 evaluating UCART22 in relapsed and refractory B-cell acute lymphoblastic leukemia.