General, Melanoma, Non-small cell lung cancer (NSCLC)
other systemic therapies
IMA203-101 is a multicenter Phase 1 study evaluating autologous T cells engineered to express a specific T-cell receptor (ACTengine® IMA203) in patients with relapsed or refractory solid tumors. Patient eligibility is confirmed through HLA-A*02:01 screening and tumor biomarker analysis. Following leukapheresis and manufacturing of the IMA203 product, patients receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance cell engraftment. The primary objective is to evaluate safety, tolerability, and the recommended Phase 2 dose (RP2D), supported by a 14-day regimen of low-dose subcutaneous IL-2 after infusion. As this is a gene therapy medicinal product (GTMP), long-term follow-up for up to 15 years is required. Key secondary endpoints include objective response rate (ORR) per RECIST 1.1 and the long-term persistence and expansion of the engineered T cells.
The IMA203-101 study evaluates a novel immunotherapy for patients with advanced solid tumors that have progressed after standard treatments. Eligibility is first determined through HLA and biomarker screening of blood and tissue samples. For eligible patients, white blood cells are collected and genetically engineered in a laboratory to create the "IMA203 product," designed to specifically recognize cancer cells. Before the modified cells are re-infused, patients undergo preparatory chemotherapy (lymphodepletion) in a hospital setting, followed by the infusion and two weeks of low-dose IL-2 support. The study's primary goal is to determine the safety and optimal dosage of this gene therapy. Due to the genetic modification of the cells, participants will be monitored for long-term safety over a period of up to 15 years.
