PBCAR0191

PBCAR0191 is an investigational, off-the-shelf allogeneic chimeric antigen receptor (CAR) T cell therapy engineered to target the CD19 antigen, primarily used in the treatment of relapsed/refractory B-cell malignancies including non-Hodgkin lymphoma (NHL) and B-cell acute lymphoblastic leukemia (B-ALL). It is designed using Precision BioSciences’ proprietary ARCUS genome editing platform and incorporates the company's patented N6 co-stimulatory domain to enhance T cell function and persistence. As an allogeneic ("donor-derived") product, PBCAR0191 aims to provide rapid availability compared to traditional autologous CAR T therapies, with reduced manufacturing times and no requirements for patient-specific cell harvest, while minimizing the risk of graft-versus-host disease (GvHD). In clinical studies, PBCAR0191 demonstrated dose- and regimen-dependent efficacy, with higher rates of complete response in patients receiving enhanced lymphodepletion regimens, and a favorable safety profile with no Grade ≥3 CRS or ICANS and no observed GvHD. The product is in phase 1/2a trials and has received FDA Fast Track Designation for B-ALL and Orphan Drug Designation for mantle cell lymphoma, a subtype of NHL[1][2][3][5][7].