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ASH 2020 | FasTCAR manufacturing platform: Safety and feasibility in B-ALL

Peihua Lu, MD, Beijing Lu Daopei Institute of Hematology, Beijing, China, discusses the results of a Phase I trial (NCT03825718) assessing the safety and feasibility of a second-generation CD19/CD22-dual directed CAR-T therapy (GC022C) using a novel manufacturing platform in patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). The FasTCAR technology can manufacture CAR T-cells within 24 hours. Results showed that the cells manufactured using FasTCAR showed less exhaustion, a higher percentage of T central memory cells, higher anti-leukemic efficacy in mouse models, and greater expansion in vitro, as compared to traditionally engineered cells. They were also more potent and faster-acting in mouse models. All patients who participated in the dose-escalation trial demonstrated a promising safety profile of the treatment with no cytokine release syndrome or neurotoxicity occurring at grade 3 or above. Early clinical data suggests the therapy is efficacious, but additional patients and longer follow-up are needed. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.