Phase Ib Study of CT011 CAR-GPC3 T Cell Therapy for Adults 18-75 With Hepatocellular Carcinoma at Risk of Recurrence After Surgery

What this Trial Is About

Researchers are evaluating CT011 autologous CAR-T cells in patients with hepatocellular carcinoma HCC who are at risk of recurrence after surgical removal of their tumor. This early-phase, open-label trial focuses on patients with CNLC stage IIIa, GPC3-positive HCC, aiming to understand the safety, effectiveness, and behavior of CT011 cells in the body after treatment. The study is exploratory and conducted across multiple centers, enrolling about 30 participants. Participants will receive a single infusion of CT011 CAR-GPC3 T cells, which have previously shown manageable safety and preliminary anti-tumor activity in patients with advanced HCC. The trial allows patients who have undergone surgical resection and have recovered, with a negative tumor margin confirmed by pathology. The treatment is tailored based on prior safety and dosing results from previous studies involving CT011. During the study, participants will be closely monitored for up to 12 months to track treatment-related side effects, recurrence-free survival, overall survival, and other measures related to tumor recurrence and spread. Researchers will also assess the metabolic activity and immune response of the infused CT011 cells. Participants will undergo regular blood tests, imaging, and clinical assessments to evaluate these outcomes and ensure safety throughout the trial.

CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical Resection