Phase I Study of GPC3 and TGF Targeting CAR-T Cell Immunotherapy for Advanced Liver Cancer

What this Trial Is About

Researchers are studying a new immunotherapy using CAR-T cells that target glypican-3 GPC3 andor soluble TGF-beta in patients with advanced hepatocellular carcinoma HCC who have tumors expressing GPC3. This phase I clinical trial aims to test the safety, tolerance, and early effectiveness of these engineered CAR-T cells in human patients. The study also plans similar evaluations in patients with lung squamous carcinoma expressing GPC3. Patients undergo tumor biopsy to confirm GPC3 expression before treatment. T cells are collected from patients blood, genetically modified to express CAR targeting GPC3 andor TGF-beta, and expanded in number. These modified cells may include additional engineered features to enhance their cancer-killing ability. The CAR-T cells are then infused back into patients systemically or locally via artery or directly into tumors. Follow-up includes monitoring clinical outcomes and safety. Participants will be closely monitored for adverse effects and response to treatment, including measuring dose-limiting toxicities within three months. Researchers will assess tumor response rates and track CAR-T cell presence in the body for up to five years. The study requires informed consent and ongoing evaluations to collect relevant clinical data throughout the trial period, which may last many years.

GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression