FDA places clinical hold on trial for off-the-shelf CAR-T for advanced myeloma
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The FDA placed a clinical hold on a phase 1 study designed to evaluate UCARTCS1A for the treatment of patients with relapsed or refractory multiple myeloma, according to a press release from the agent’s manufacturer.
The agency placed the MELANI-01 trial on hold after one patient, who received UCARTCS1A (Cellectis) at the second dose level evaluated in the study, experienced fatal treatment-emergent cardiac arrest. A clinical investigation into the death is ongoing, according to the manufacturer.
“We share the FDA’s commitment to patient safety and are working collaboratively with the agency and the investigators to resolve this clinical hold,” Carrie Brownstein, MD, chief medical officer at Cellectis, said in the press release. “The safety of patients enrolled in our clinical trials is our utmost priority and we at Cellectis remain committed to safely resuming the clinical development of the UCART product candidate targeting CS1 for patients with multiple myeloma.”
UCARTCS1A 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. MELANI-01 is a first-in-human study designed to evaluate the safety and efficacy of UCARTCS1A in patients with relapsed or refractory multiple myeloma, as well as determine a maximum tolerated dose of the agent and recommended dose for phase 2 study.
Cellectis was in the process of “executing updates to the clinical protocol” when the FDA issued the hold, according to the press release. This included recommending the lower dose level (DL1) for additional enrollment in the study and using DL1 as the recommended phase 2 dose “based on an assessment of the preliminary clinical and translational data,” the press release stated.
The company plans to work with the FDA to address the agency’s concerns and develop an updated protocol for the MELANI-01 trial that enhances patient safety, according to the press release.
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