Study of Genetically Modified T Cells with IMA203 or IMA203CD8 Alone or With Nivolumab in Adults with Recurrent or Refractory Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of genetically modified T-cell therapies called IMA203 and IMA203CD8, used alone or combined with the drug nivolumab, in patients with solid tumors that express a specific antigen known as PRAME. This study focuses on patients with recurrent or refractory solid tumors who have limited treatment options and aims to understand how well these therapies are tolerated and their effects on tumors. The trial includes adult patients who meet specific health and tumor criteria, including a positive HLA type and tumor antigen expression confirmed by a specialized diagnostic test. The study begins with screening that includes HLA testing and tumor tissue analysis. Eligible patients undergo leukapheresis to collect white blood cells, which are genetically modified to produce the IMA203 or IMA203CD8 products. Before receiving the cell infusion, patients undergo lymphodepletion with chemotherapy drugs cyclophosphamide and fludarabine to help the modified cells persist longer. The cell therapy is then infused in the hospital, followed by a low dose of IL-2 injections for up to 10 days if applicable. In one group, patients also receive nivolumab intravenously after the cell therapy. The study has multiple treatment groups with different dosing strategies and combinations. Participants are closely monitored throughout treatment and follow-up, which lasts up to five years after infusion. Assessments include tumor response evaluations, safety checks for side effects, and tests to measure the persistence of the modified T cells. Quality of life is also evaluated over time. This long-term follow-up helps researchers understand the therapys effects and any lasting impacts. The study does not involve randomization or blinding, and patients continue to receive care while enrolled in the trial.

ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors