About this trial
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.
Eligibility criteria
Qualifiers
Recurrent malignant glioma (WHO grade IV)
Pathologically confirmed and imaging-defined recurrent glioma
ECOG score of 0-2
Age >=18 years
Disqualifiers
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
Trial design
Treatments tested in this trial
- IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody
Treatment groups
Sponsors and collaborators
Ming Yang
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Pecking Union Medical College Hospital, Department of Neurosurgery
Collaborator
Emergency General Hospital, Department of Neurosurgery
Collaborator
Peking University International Hospital
Collaborator