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IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody for Recurrent Malignant Glioma

NCT07481721 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-03-19

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent Malignant Glioma

Interventions

BIOLOGICAL

IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody

Autologous IL13Rα2-targeted CAR-T cells engineered to secrete anti-PD-L1 antibody will be administered after lymphodepleting pretreatment. The study includes peripheral intravenous infusion alone or peripheral intravenous infusion combined with intraventricular injection. Peripheral dose-escalation levels are 1×10\^6 cells/kg, 3×10\^6 cells/kg, and 1×10\^7 cells/kg. In the combined administration strategy, the intraventricular dose is 20%-30% of the peripheral dose, with adjustment based on patient tolerability. Patients will be monitored in the ICU or a dedicated inpatient setting during infusion and for adverse events including CRS and ICANS after infusion.

Sponsors & Collaborators

  • Pecking Union Medical College Hospital, Department of Neurosurgery

    collaborator UNKNOWN

  • Emergency General Hospital, Department of Neurosurgery

    collaborator UNKNOWN

  • Peking University International Hospital, Department of Neurosurgery

    collaborator UNKNOWN

  • Ming Yang

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07481721 on ClinicalTrials.gov