Caribou Biosciences Announces Positive Data from ANTLER Phase 1 Trial Demonstrating Efficacy and Durability of Vispa-cel (CB-010), an Allogeneic CAR-T Cell Therapy, on Par with Autologous CAR-T Cell Therapies

Core Insights - Caribou Biosciences, Inc. announced positive results from the ANTLER phase 1 clinical trial for vispacabtagene regedleucel (vispa-cel), an allogeneic anti-CD19 CAR-T cell therapy for patients with relapsed or refractory B cell non-Hodgkin lymphoma [1][4][8] Clinical Trial Results - The ANTLER trial enrolled 84 patients, with a confirmatory cohort of 22 CD19-naïve second-line large B cell lymphoma patients, demonstrating an 82% overall response rate (ORR), 64% complete response (CR) rate, and 51% progression-free survival (PFS) at 12 months [2][4][5] - In a cohort of 35 patients receiving an optimized profile of vispa-cel, the results showed an 86% ORR, 63% CR rate, and 53% PFS at 12 months, with a median follow-up of 11.8 months [6][4] Safety Profile - Vispa-cel exhibited a generally well-tolerated safety profile, with treatment-emergent adverse events occurring in ≥25% of patients, including thrombocytopenia (62%), cytokine release syndrome (CRS; 55%), and anemia (52%) [7][9] - No cases of graft-versus-host disease (GvHD) or grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) were reported in the confirmatory and optimized profile cohorts [7][9] Regulatory Path and Future Plans - The FDA has recommended a randomized, controlled phase 3 trial for vispa-cel in second-line large B cell lymphoma, which will evaluate approximately 250 patients [12][8] - The primary endpoint of the upcoming trial will be progression-free survival, with secondary endpoints including overall response rate, complete response rate, and overall survival [12] Company Overview - Caribou Biosciences is focused on developing transformative therapies using its CRISPR genome-editing platform, with vispacabtagene regedleucel being a key candidate for hematologic malignancies [18]