FDA clears IND application for allogeneic CAR-T to treat advanced non-Hodgkin lymphoma
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The FDA cleared an investigational new drug application for PBCAR19B, a chimeric antigen receptor T-cell therapy for patients with relapsed or refractory non-Hodgkin lymphoma, according to the agent’s manufacturer.
PBCAR19B (Precision BioSciences) is an allogeneic, gene-edited CAR T-cell therapy that targets the CD19 protein on the surface of cancer cells.
The therapy, manufactured from healthy donor cells using Precision’s proprietary ARCUS genome editing platform, is designed to enhance the persistence of allogeneic CAR T cells after infusion by preventing rejection by a patient’s T cells and natural killer cells.
The agent is being developed in the United States as part of a collaborative agreement between Precision Biosciences and Servier.
“We are pleased to receive IND clearance for PBCAR19B, which has shown in preclinical studies to delay both T cell and natural killer cell-mediated allogeneic rejection,” Matt Kane, MS, MBA, CEO of Precision BioSciences, said in a company-issued press release. “We believe that the ability to reduce rejection by both cell types holds potential for improved persistence of allogeneic CAR T cells and that, by bringing PBCAR19B into the clinic while continuing to develop our lead allogenic candidate, PBCAR0191, we have two opportunities to achieve our goal of producing deep and durable clinical responses.”
The IND clearance will allow Precision Biosciences to begin a first-in-human, phase 1 clinical trial of PBCAR19B for patients with relapsed or refractory NHL. The open-label, dose-escalation study will evaluate the safety and clinical activity of a single dose of PBCAR19B at three dose levels.
The study’s primary objective will be to identify the maximum tolerated dose for subsequent study, as well as any dose-limiting toxicities.
Precision’s lead allogeneic CAR T-cell therapy — PBCAR0191 —previously received fast track designation by the FDA for treatment of advanced B-cell precursor acute lymphoblastic leukemia and mantle cell lymphoma.
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