1. Nov 19, 2020

FDA lifts clinical hold on the phase 1 trial for R/R multiple myeloma

The U.S. Food and Drug Administration lifted a clinical hold on the Phase 1 MELANI-01 trial evaluating UCARTCS1 (Cellectis) for the treatment of patients with relapsed or refractory multiple myeloma (MM), according to a company press release.

Cellectis said they have been working with the FDA to address concerns related to the MELANI-01 clinical protocol to enhance patient safety. The company is currently working with clinical site staff and investigators to get local approval to reopen the trial and resume patient enrollment.

“We remain confident in the potential clinical benefit of UCARTCS1 product candidate for patients with relapsed/refractory multiple myeloma, a widely unmet medical need that Cellectis will continue to address. 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, in the press release.

Read the full press release here.