FDA lifts clinical hold on Cellectis' early-stage UCARTCS1 study in multiple myeloma

• Cellectis announces that the FDA has lifted the clinical hold on the Phase 1 MELANI-01 trial evaluating the UCARTCS1 product candidate for the treatment of patients with relapsed or refractory multiple myeloma (MM).
• Cellectis worked closely with the FDA to address the agency’s requests, which include adjustments to the MELANI-01 clinical protocol designed to enhance patient safety.
• “The safety of patients enrolled in our clinical trials remains our priority, and we are committed to resuming the clinical development of this promising program,” said Carrie Brownstein, MD, Chief Medical Officer, Cellectis.
• Patient enrollment is ongoing in Cellectis’ two other Phase 1 dose escalation trials: AMELI-01 evaluating UCART123 in acute myeloid leukemia and BALLI-01 evaluating UCART22 in B-cell acute lymphobastic leukemia.
• https://seekingalpha.com/news/3637357-fda-lifts-clinical-hold-on-cellectis-early-stage-ucartcs1-study-in-multiple-myeloma