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Precision BioSciences Doses First Patient in Phase 1 Allogeneic CAR T Clinical Trial of PBCAR19B Immune Evading Stealth Cell for Relapsed/Refractory Non-Hodgkin Lymphoma
DURHAM, N.C.--(BUSINESS WIRE)-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo
About this update from Precision Biosciences, Inc.
[{"type":"text","content":" DURHAM, N.C.--(BUSINESS WIRE)--\nPrecision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS® genome editing platform, today announced that the first patient has been dosed in its Phase 1 clinical trial with PBCAR19B, an immune evading allogeneic CAR T stealth cell candidate for patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL).\n\n“We are excited to have dosed the first patient in our Phase 1 trial of PBCAR19B, a next-generation, CD19-targeted candidate incorporating our immune evading stealth cell technology. This is our fourth CAR T program in the clinic, demonstrating the modularity of ARCUS for allogeneic CAR T therapies,” said Alan List, M.D., Chief Medical Officer of Precision BioSciences. “Moreover, we believe that our ARCUS-edited stealth cell technology holds the potential to safely improve the persistence of allogeneic CAR T cells without the need for prolonged immunosuppression, which may ultimately lead to deeper and more durable responses for patients.”\n\nThe Phase 1 study will be a non-randomized, open-label, single-dose, dose-escalation and dose-expansion study designed to evaluate the safety and clinical activity of PBCAR19B at flat dose levels beginning at 2.7 × 108 with the ability to dose up to 8.1 × 108 CAR T cells per patient, following standard lymphodepletion1 in patients with R/R NHL. The first dose level of PBCAR19B is comparable to dose level 3 of the PBCAR0191 CAR T. The primary objective of the study is to identify the maximum tolerated dose and any dose-limiting toxicities. Clinical trial material for this study is generated at the Company’s in-house Manufacturing Center for Advanced Therapeutics (MCAT) in Durham, North Carolina.\n\nAbout PBCAR19B (Clinical Trials Study Identifier: NCT04649112)\nPBCAR19B is a next-generation, immune evading stealth cell candidate for patients with CD19-positive malignancies such as R/R NHL. PBCAR19B is designed to improve the expansion and persistence of allogeneic CAR T cells following infusion by reducing rejection by T cells and 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) mol...