FDA Lifts Clinical Hold on Phase 1 MELANI-01 Trial for R/R Multiple Myeloma

The FDA has lifted the clinical hold on the phase 1, open-label, first-In-human, dose escalation MELANI-01 trial, which is evaluating UCARTCS1 for the treatment of patients with relapsed or refractory multiple myeloma, according to Cellectis.

UCARTCS1 is an allogeneic, off-the-shelf, gene-edited T-cell product candidate designed by Cellectis for the treatment of CS1/SLAMF7-expressing hematologic malignancies. CS1 (SLAMF7) is highly expressed on multiple myeloma tumor cells.

The company indicated it has been working with the FDA to address its requests, including adjustments to the MELANI-01 trial protocol designed to enhance patient safety. Cellectis also noted it continues to work with clinical site staff and investigators to acquire the required local approvals 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,” Carrie Brownstein, MD, chief medical officer at Cellectis, said in a press release. “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.”

Patient enrollment is also ongoing in 2 other proprietary phase 1 dose escalation trials conducted by Cellectis, including 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.

Reference:

FDA Lifts Clinical Hold on MELANI-01 Study Evaluating Cellectis’ Product Candidate UCARTCS1 in Multiple Myeloma [news release]. New York, New York. Published November 17, 2020. Accessed November 18, 2020. https://www.cellectis.com/en/press/fda-lifts-clinical-hold-on-melani-01-study-evaluating-cellectis-product-candidate-ucartcs1-in-multiple-myeloma/