CELL INTELLIGENCE · 肿瘤细胞治疗研究

Inclusion Criteria:

* Recurrent malignant glioma (WHO grade IV)
* Pathologically confirmed and imaging-defined recurrent glioma
* ECOG score of 0-2
* Age \>=18 years
* Male or female
* Life expectancy \>3 months

Exclusion Criteria:

* Severe immune suppression or autoimmune diseases
* Severe cardiac, liver, kidney, or other major organ dysfunction
* Pregnant or breastfeeding women
* Prior treatment with immune checkpoint inhibitors or other immunotherapies
* Other conditions posing significant risk to the patient or preventing adherence to the study protocol

主要终点：Incidence of Grade 3 or Higher Treatment-Related Adverse Events · Incidence of Grade 3 or higher treatment-related adverse events after infusion of IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody, including serious adverse events. Adverse event severity will be graded according to CTCAE version 5.0. · From first CAR-T cell infusion through Day 28；Progression-Free Survival · Progression-free survival, defined as the time from first CAR-T cell infusion to documented disease progression or death from any cause, whichever occurs first. · Up to 2 years after first CAR-T cell infusion
次要终点：Incidence and Maximum Grade of Cytokine Release Syndrome；Incidence and Maximum Grade of Immune Effector Cell-Associated Neurotoxicity Syndrome；Overall Survival；Objective Response Rate by MRI/PET-CT；Change in Tumor Volume on Imaging；Change in Quality of Life Score Measured by EORTC QLQ-C30；Change in Karnofsky Performance Status Score；Change in Modified Rankin Scale Score

• Single Treatment Arm · EXPERIMENTAL · Participants with recurrent malignant glioma will receive IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody within a single-arm, open-label study framework. Two administration strategies are planned according to investigator assessment and protocol procedures: peripheral intravenous infusion alone, or peripheral intravenous infusion combined with intraventricular injection. Dose escalation is planned, including 1×10\^6 cells/kg, 3×10\^6 cells/kg, and 1×10\^7 cells/kg for peripheral infusion. For the combined administration strategy, the intraventricular dose is 20%-30% of the peripheral dose, adjusted according to tolerability.

This clinical study is designed to evaluate the safety and efficacy of IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody in patients with recurrent malignant glioma. This trial is a multicenter, open-label, non-randomized, single-arm investigator-initiated trial (IIT). Patients who have recurrent malignant glioma will receive IL13Rα2 CAR-T cell therapy and will be monitored for safety, adverse events (AEs), and efficacy outcomes, including overall survival (OS) and progression-free survival (PFS). The study will help assess the potential of this innovative therapy in the treatment of glioma and its ability to control tumor growth by targeting both IL13Rα2 and PD-L1.