FDA lifts hold on clinical trial for allogeneic CAR-T for advanced myeloma
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The FDA lifted its clinical hold on a study evaluating UCARTCS1 for the treatment of patients with relapsed or refractory multiple myeloma, according to a press release from the agent’s manufacturer.
UCARTCS1 (Cellectis) is an investigational, allogeneic, gene-edited chimeric antigen receptor T-cell therapy that targets the CS1/SLAMF7 antigen on the surface of hematologic cancer cells.
Regulators had placed the clinical hold on the phase 1 MELANI-01 trial, a dose-escalation study designed to evaluate UCARTCS1 among patients with relapsed or refractory multiple myeloma. The FDA instituted the hold after one patient who received the investigational cell therapy experienced fatal treatment-emergent cardiac arrest.
Cellectis worked with the FDA to adjust the trial’s clinical protocol to enhance patient safety, per the agency’s request, according to the press release. The manufacturer also has been working with clinical staff at local trial sites to obtain necessary approvals and resume patient enrollment in the study, the release stated.
“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 of Cellectis, said in the 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.”
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