A Phase 1 Multicenter Open-Label Study of CB-010 a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients with Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
Brief description of study
T cells are an integral part of the immune system that kills cancer cells in the body. T cells have been harvested from peripheral blood and modified to express chimeric antigen receptors (CARs) to direct their antitumor activity toward malignant cells. Despite their clinical benefits, autologous CAR-T cell therapies present barriers for some patients because of insufficiencies in patient T cells. In contrast, allogeneic CAR-T cells may offer a significant benefit to patients who are ineligible for autologous CAR-T cell products, patients who may be at risk for manufacturing failure of their cells, patients with insufficient T cells for product manufacture, patients refractory to treatment, or those for whom bridging therapy may deteriorate performance status. CB-010 is a product of clustered regularly interspaced short palindromic repeats (CRISPR)- based gene editing designed to create a human T cell product with specific capacity to target diseased B cells and to function in an environment of intrinsic immunosuppression to treat disease. This approach to cancer therapy aims to provide treatment for patients with limited treatment options for relapsed/refractory (r/r) B cell non-Hodgkin lymphoma (B-NHL). Primary Objective: To evaluate the safety and tolerability of CB-010 therapy (plus lymphodepletion) in patients with r/r B-NHL subtypes to define the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) to determine RP2D.
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