Tris-CAR-T Cell Therapy for Recurrent Glioblastoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 30, 2023

Primary Completion Date

November 1, 2024

Study Completion Date

November 1, 2032

Conditions
Recurrent Glioblastoma
Interventions
GENETIC

Inverse correlated dual-target, truncated IL7Ra modified CAR -expressing autologous T-lymphocytes.

"Intratumoral or intraventricular administration via Ommaya reservoir.~Dose level 0: 1×10\^7 autologous Tris-CAR-T cells, at least one dose, maximum 6 doses, 2 patients.~Dose level 1: 1×10\^8/ 5×10\^6 autologous Tris-CAR-T cells, at least one dose, maximum 6 doses, 2 patients. The dose of Dose level 1 will refer to the adverse effect of Dose level 0. When dose-related side effects occurred in 2 patients in the Dose level 0, the dose should be reduced to 5×10\^6 cells.~In Dose levels 0 and 1, the second dose will be infused 28 days after the first dose, and the subsequent doses will be administered weekly.~Dose level 2: 5×10\^7 autologous Tris-CAR-T cells, weekly administered, maximum 8 weeks, 4 patients. If the results of Dose levels 0 and 1 suggested that dose-related toxic side effects could have occurred in the 1×10\^7cells dose, the researcher would re-determine the dosage of the multidose clinical exploration study."

Trial Locations (1)

100070

RECRUITING

Beijing Tiantan Hospital, Beijing

All Listed Sponsors
collaborator

Beijing Neurosurgical Institute

OTHER

collaborator

Tasly Pharmaceutical Group Co., Ltd

INDUSTRY

lead

Beijing Tiantan Hospital

OTHER