Immunotherapy Using IL-15 and IL-21 Enhanced GPC3-Specific CAR T Cells for Adults with GPC3-Positive Solid Tumors

What this Trial Is About

Researchers are evaluating a new immunotherapy treatment for adults with solid tumors that express the protein glypican-3 GPC3 on their surface. This study explores genetically engineered T cells called 21.15.GPC3-CAR T cells, which are designed to better recognize and kill cancer cells. These T cells have been modified with additional genes, IL15 and IL21, to help them grow and stay active longer in the body. The study also includes a safety feature allowing the removal of these T cells if severe side effects occur using an experimental drug called AP1903. The treatment process involves collecting blood from participants to grow and genetically modify their T cells in the laboratory. Before receiving the T-cell infusion, participants undergo chemotherapy with cyclophosphamide and fludarabine to reduce their existing T cells, allowing the new T cells to grow better. The modified T cells are then infused into the participant 48 to 72 hours after chemotherapy. This is a dose escalation study where different doses of the 21.15.GPC3-CAR T cells will be tested to find a safe level. Participants may receive additional infusions if their condition does not worsen after 4 weeks. During the study, participants will have regular medical exams, blood tests, tumor scans, and biopsies to monitor safety and treatment effects. Blood samples will be collected at multiple time points up to 15 years to study how long the modified T cells last and if there are long-term side effects. The study team will also monitor tumor markers and overall health, with yearly follow-ups after the initial treatment period. The total participation time is up to 15 years to ensure comprehensive long-term monitoring.

Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells