Allogeneic CAR-T cell therapy treats leukemia and obtains FDA fast-track designation.

Precision Bioscience corporation announced that the U.S. Food and Drug Administration (FDA) has awarded its isometremic antigen-insignidant (CAR-T) cell therapy PBCAR0191 a fast-track designation for the treatment of advanced pregenicular B-cell acute lymphoblastic leukemia (B-ALL).
Precision carefully selected high-quality T-cells from healthy feeds as starting materials and then modified T-cells in-body using its unique ARCUS genome editing technology.
by inserting the CAR gene into the T-cell recipient (TCR) position, the process knocks out the CAR while knocking out the TCR, thus preventing the graft from being resistant to host disease.
in vitro amplification and then returned to the patient for treatment.
photo source: PBCAR0191 is currently in Phase 1/2a studies to assess its safety and tolerance in adult R/R B cell acute lymphoblastic leukemia (B-ALL) and R/R non-Hodgkin's lymphoma (NHL) patients.
the NHL population, including patients with set cell lymphoma, PBCAR0191 was awarded the FDA's "Orphan Drug Title" for treatment of this subsype.
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