Learn more about our allogeneic CAR T clinical trials:

Azercabtagene zapreleucel (azer-cel; PBCAR0191 )is an investigational anti-CD19 allogeneic CAR T candidate being evaluated in a Phase 1/2a clinical trial of adult subjects with relapsed or refractory (R/R) non-Hodgkin lymphoma. This study is a multicenter, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study. Made from donor-derived T cells modified using our ARCUS genome editing technology, azer-cel recognizes the well characterized tumor cell surface protein CD19, an important and validated target in several B-cell cancers and is designed to avoid graft-versus-host disease, a significant complication associated with donor-derived, cell-based therapies. All subjects who receive a dose of azer-cel will be followed in a separate long-term follow-up study for 15 years after exiting this study. We have received orphan drug designation for azer-cel from the U.S. Food and Drug Administration for the treatment of ALL and MCL, as well as Fast Track Designation for azer-cel for the treatment of B-ALL.

For more information, visit www.clinicaltrials.gov, study identifier number NCT03666000.

PBCAR19B is a next-generation, anti-CD19 immune-evading stealth cell candidate being evaluated in a Phase 1 study of adult subjects with relapsed/refractory non-Hodgkin lymphoma. This study is a nonrandomized, open-label, single-dose, dose-escalation and dose-expansion study.  PBCAR19B is designed to improve the expansion and persistence of allogeneic CAR T cells following infusion by reducing rejection by T cells and natural killer (NK) cells. In addition to the CAR gene, the PBCAR19B stealth cell vector carries a short hairpin RNA that suppresses expression of beta-2 microglobulin, a component of Class I Major Histocompatibility Complex (MHC) molecules found on the cell surface. Reducing or knocking-down Class I MHC expression on allogeneic CAR T cells has been shown to reduce CAR T cell killing by cytotoxic T cells. The PBCAR19B vector also carries an HLA-E gene intended to reduce rejection of CAR T cells by NK cells that can be stimulated as a result of reduced MHC molecule expression on the cell surface.

For more information, visit www.clinicaltrials.gov, study identifier number NCT04649112.

Expanded Access

Precision BioSciences is currently investigating multiple off-the-shelf allogeneic CAR T cell therapy candidates as potential treatment options for patients with hematologic blood cancers. Precision does not currently offer patients Expanded Access to investigational therapies outside of clinical trials. We believe that facilitating patient participation in our ongoing clinical trials is the best way to speed investigation and subsequent approval of candidate therapies for broad access by providing a rigorous assessment of the products’ benefits, risks, and appropriate uses for patients. Eligibility requirements and more information about our clinical trials is available at clinicaltrials.gov.