Precision BioSciences announced the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for PBCAR269A, the Company’s third allogeneic chimeric antigen receptor (CAR) T cell therapy candidate. The FDA has also granted Orphan Drug Designation to PBCAR269A for the treatment of multiple myeloma.
Precision plans to initiate dosing in a Phase 1 clinical trial in 2020. The multicenter, open-label dose-escalation and dose-expansion clinical trial will enroll adult relapsed/refractory multiple myeloma patients. The trial will be conducted at multiple U.S. sites.
“In preclinical disease models, PBCAR269A has demonstrated no evidence of graft-versus-host disease at doses that resulted in potent anti-tumor activity,” commented Chris Heery, Chief Medical Officer of Precision BioSciences. “There remains significant unmet need in the treatment of relapsed/refractory multiple myeloma, and we are excited to begin clinical trials with an off-the-shelf CAR T therapy candidate in this setting.”
PBCAR269A is an allogeneic CAR T therapy candidate which targets the B-cell maturation antigen (BCMA).