FDA Lifts Hold on Trial Assessing CAR T-Cell Product for Relapsed or Refractory Multiple Myeloma

December 30, 2020
Darlene Dobkowski, MA

The Food and Drug Administration lifted a clinical hold on the MELANI-01 trial, evaluating UCARTCS1A, a CAR T-cell product in patients with relapsed or refractory multiple myeloma.

Cellectis announced that the Food and Drug Administration (FDA) lifted a clinical hold on its phase 1 MELANI-01 trial to evaluate the CAR T-cell product UCARTCS1A to treat patients with relapsed or refractory multiple myeloma.

The clinical hold, which orders a company to delay or suspend a trial, was placed on the phase 1 MELANI-01 trial back in July 2020 after a safety report detailed a patient who died after treatment-emergent cardiac arrest. Since the hold was placed, the company worked with the FDA to address several requests including adjusting the clinical protocol to improve patient safety, according to a press release from the company.

“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,” said Dr. Carrie Brownstein, chief medical officer of Cellectis, in the release. “The safety of patients enrolled in our clinical trials remain our priority, and we are committed to resuming the clinical development of this promising program.”

The phase 1 MELANI-01 trial is a first-in-human study to evaluate safety and effectivennses of UCARTCS1 product candidate in patients with relapsed or refractory multiple myeloma. In particular, UCARTCS1 is an allogeneic (or obtained by a donor), gene-edited T-cell product to treat CS1/SLAMF7-expressing hematologic malignancies, according to the release.

This study is also being conducted to determine the maximum tolerated dose of UCARTCS1, according to its clinical trial listing. The primary outcome of interest is the safety of UCARTCS1, which includes adverse and serious adverse events over a 24-month period.

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