The FDA has lifted its clinical hold on the phase I MELANI-01 trial evaluating the chimeric antigen receptor (CAR) T-cell therapy UCARTCS1 for the treatment of patients with relapsed or refractory multiple myeloma.
UCARTCS1 is an allogeneic, off-the-shelf CAR T-cell product manufactured by Cellectis, targeted against the CS1/SLAMF7 antigen. Dosing in the phase I trial began in October 2019, and the clinical hold was requested in June 2020 following a safety report regarding one patient who experienced treatment-emergent fatal cardiac arrest. Since then, Cellectis has been working with the FDA to adjust safety protocols for the MELANI-01 trial prior to reopening the trial and resuming enrollment, the company stated in a press release.
Two other phase I trials evaluating Cellectis’ UCART123 for the treatment of relapsed/refractory acute myeloid leukemia and UCART22 for released/refractory B-cell acute lymphocytic leukemia are currently enrolling patients.