The trial NCT036861243 is an open-label Phase?1 study evaluating the safety, tolerability, and pharmacokinetics of IMA203, an autologous T-cell therapy, in adults with advanced solid tumors. The primary objective is to assess safety and identify dose-limiting toxicities. Eligible patients have histologically or cytologically confirmed solid tumors for which no standard therapy is available. Eligibility is confirmed via HLA typing and biomarker analysis of tumor biopsies. The intervention includes leukapheresis, manufacturing of IMA203 from autologous T cells, lymphodepletion with cyclophosphamide and fludarabine, followed by IMA203 infusion and 14-day subcutaneous IL-2 administration. Key secondary endpoints include pharmacokinetics, immunologic responses, objective tumor responses, and long-term safety monitoring for up to 15 years.
This Phase?1 study investigates a novel cell therapy called IMA203 in adults with advanced solid tumors. The main goal is to assess safety and how the body responds to the treatment. Eligibility is determined through blood tests and tumor biopsies. IMA203 is manufactured from the patient’s own white blood cells. Before infusion, patients receive a preparatory regimen to enhance the therapy’s persistence. After infusion, a low dose of interleukin-2 (IL-2) is administered for two weeks, and patients are monitored for long-term safety for up to 15 years.
