Phase I Study of IL13Ralpha2 CAR T Cell Therapy After Chemotherapy for Advanced Melanoma and Other Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating a new treatment using modified immune cells called IL13Ralpha2 CAR T cells for patients with advanced melanoma or other metastatic solid tumors. This phase I trial aims to find the safest dose of these gene-modified cells after a chemotherapy conditioning regimen and to see how long the cells remain in the body and if they can attack cancer cells. The study also explores immune responses triggered by this therapy and monitors for side effects like cytokine release syndrome. Participants receive chemotherapy drugs cyclophosphamide and fludarabine intravenously before getting the IL13Ralpha2 CAR T cell infusion. The trial includes a dose-escalation phase followed by dose expansion. Patients undergo biopsies, CT, PET, and MRI scans at various points, and blood samples are collected throughout the study. If their disease progresses, they may get a second infusion of the CAR T cells. During the trial, patients are closely monitored for adverse events and response to treatment using scans and blood tests. Follow-up visits occur every 2 to 3 months for the first 2 years, then every 6 months for 3 years, and annually for at least 15 years to assess long-term safety and effectiveness. The main outcomes include side effects within 90 days and dose-limiting toxicity within 28 days after cell infusion.

Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors