FDA grants fast track designation to allogeneic CAR T-cell therapy for advanced ALL
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The FDA granted fast track designation to PBCAR0191, a chimeric antigen receptor T-cell therapy for treatment of advanced B-cell precursor acute lymphoblastic leukemia, according to the agent’s manufacturer.
PBCAR0191 (Precision BioSciences) is an investigational allogeneic CAR T-cell therapy derived from healthy donor cells.
The product starts with donor T cells that are gene edited using Precision BioSciences’ proprietary ARCUS technology to insert the CAR gene at the T-cell receptor locus. This process is designed to prevent graft-versus-host disease.
PBCAR0191 is being developed in the United States as part of a collaborative agreement between Precision Biosciences and Servier.
“We continue to work toward demonstrating that PBCAR0191 ... may play a role in the treatment paradigm of advanced malignancies,” Chris Heery, MD, chief medical officer of Precision BioSciences, said in a company-issued press release. “We believe the balance of safety and efficacy, plus the accessibility of allogeneic cell therapies, may fill a void left by autologous CAR T-cell therapies. This designation provides more flexibility as we attempt to identify the optimal patient population in which to seek regulatory approval.”
A nonrandomized, multicenter phase 1/phase 2 study is evaluating the safety and tolerability of PBCAR0191 among adults with relapsed or refractory B-cell ALL or non-Hodgkin lymphoma.
The FDA previously granted orphan drug designation to PBCAR0191 for patients with mantle cell lymphoma, an aggressive subtype of non-Hodgkin lymphoma.
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