Clinical Research Directory

Tris-CAR-T Cell Therapy Targeting CD44 and CD133 in Newly Diagnosed Glioblastoma

This is an investigator-initiated, randomized, open-label, parallel-controlled clinical study designed to evaluate the efficacy and safety of locally administered Tris-CAR-T cells in adults with newly diagnosed glioblastoma. A total of 60 postoperative participants with IDH-wildtype WHO CNS grade 4 glioblastoma will be randomized 1:1 to the experimental group or the control group, with 30 participants in each group. Participants in the experimental group will receive Ommaya reservoir implantation followed by local intratumoral or intraventricular Tris-CAR-T cell injections, and then standard temozolomide-based chemoradiotherapy and adjuvant temozolomide. If tumor progression occurs during Tris-CAR-T cell therapy, Tris-CAR-T treatment will be discontinued, and participants will transition to standard temozolomide-based chemoradiotherapy. Participants in the control group will receive standard temozolomide-based chemoradiotherapy and adjuvant temozolomide. The primary objective is to evaluate progression-free survival. Secondary objectives include overall survival, 12-month objective response rate, 12-month disease control rate, and safety.