Precision BioSciences’ (NASDAQ:DTIL) allogeneic chimeric antigen receptor (CAR-T) cell therapy, PBCAR0191, received FDA fast track designation for the treatment of advanced B-cell precursor acute lymphoblastic leukemia.
PBCAR0191 is currently being evaluated in a Phase 1/2a clinical trial in adult patients with relapsed/refractory acute lymphoblastic leukemia and relapsed/refractory non-Hodgkin lymphoma.
“Fast track designation is intended to fill an unmet medical need by accelerating the development of agents for patients in need of potentially better therapeutic options,” Dr. Chris Heery, Precision BioSciences’ CMO, said in a statement.
“We continue to work toward demonstrating that PBCAR0191, as well as our other two allogeneic CAR-T clinical programs, may play a role in the treatment paradigm of advanced malignancies in the future. We believe the balance of safety and efficacy plus the accessibility of allogeneic cell therapies may fill a void left by autologous CAR-T therapies,” he added.
PBCAR0191 previously received FDA orphan drug designation for the treatment of mantle cell lymphoma.
