Decentralized cell therapy manufacturing

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Galapagos to Present New ATALANTA-1 CAR-T Data at EHA 2025, Highlighting Low Toxicity and Rapid, Decentralized Delivery of Fresh, Early-Memory-Enriched GLPG5101 in R/R NHL
Globenewswireยท 2025-06-12 20:01
Core Insights - The ongoing ATALANTA-1 Phase 1/2 study of Galapagos NV's investigational CD19 CAR T-cell therapy, GLPG5101, shows low rates of high-grade toxicities in heavily pretreated relapsed refractory non-Hodgkin's lymphoma patients [1][2] - The study highlights the effectiveness of a decentralized manufacturing platform that allows for rapid delivery of fresh CAR-T cells, significantly reducing patient attrition rates [2][8] Group 1: Study Overview - The ATALANTA-1 study includes 64 patients with various subtypes of relapsed refractory non-Hodgkin's lymphoma, demonstrating the feasibility of delivering fresh, stem-like early memory cell therapy with a median vein-to-vein time of seven days [3][5] - 95% of patients received fresh GLPG5101 without the need for cytotoxic bridging therapy, with 89% receiving treatment within 7 days post-leukapheresis [5][6] Group 2: Safety and Efficacy Data - The study reported a 5% attrition rate, significantly lower than the up to 30% rates seen in other clinical trials, indicating a manageable safety profile [2][5] - The majority of treatment-emergent adverse events were hematological, with low incidences of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) [5][6] Group 3: Manufacturing and Delivery Innovations - Galapagos' decentralized manufacturing platform enables shorter vein-to-vein times and the use of fresh, early memory phenotype cells, potentially expanding CAR-T therapy access [2][8] - The platform utilizes an end-to-end workflow management system and automated manufacturing, enhancing patient experience and physician visibility [8][9] Group 4: Future Directions - The ATALANTA-1 study is currently enrolling patients in the U.S. and Europe, with plans to amend the protocol to include chronic lymphocytic leukemia [7][12] - The primary objective of the Phase 2 part of the study is to evaluate the Objective Response Rate (ORR), while secondary objectives include safety and feasibility assessments [7]