Fuzhou Ruiqi Biotechnology Co., Ltd.

To evaluate the safety, tolerability and preliminary efficacy of TX103 in subjects with B7-H3-positive recurrent or progressive grade 4 glioma; to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of TX103 for intracranial reinfusion based on dose-limiting toxicity (DLT) and/or optimal biological dose; to explore the pharmacokinetics, pharmacodynamics and immune response after treatment

Phase Ia: Dose escalation phase Main objectives: 1) Evaluate the safety and tolerability of intravenous or intraperitoneal infusion of TX103 CAR-T cells; 2) Determine the maximum tolerated dose (MTD) and/or recommended dose for phase 2 (RP2D) of intravenous or intraperitoneal infusion of TX103 CAR-T cells based on dose-limiting toxicity (DLT) and/or optimal biological dose Secondary objectives: 1) Evaluate the efficacy of intravenous or intraperitoneal infusion of TX103 CAR-T cells; 2) Evaluate the clinical pharmacological characteristics of different administration routes and dosages of TX103 CAR-T. Phase Ib: Extension phase Main objectives: Explore the population of subjects that may benefit and preliminarily evaluate the anti-tumor activity of intravenous or intraperitoneal infusion of TX103 CAR-T cells. Secondary objectives: 1) To evaluate the safety of intravenous or intraperitoneal reinfusion of TX103 CAR-T cells; 2) To evaluate the clinical pharmacological characteristics of TX103CAR-T at different administration routes and dosages.