drugset / Trial / NCT07481721
IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody for Recurrent Malignant Glioma
Phase 1
Not yet recruiting
24 enrolled
Ming Yang
Emergency General Hospital, Department of Neurosurgery · collabPecking Union Medical College Hospital, Department of Neurosurgery · collabPeking University International Hospital · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-05-01
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Publications
- Background Li X, Shang X, Liu J, Zhang Y, Jia X, Li H, Wang Y, Gao J, Ma X, Zhang X, Rong X, Gan W, Zhang Y, Chen J, Wang L, Bao Z, He L, Yan X, Liu Y, Shao J, Xiao Z, Wang Z, Zhu H, Wang Z, Wu Y, Huang Y. Intrathecal CRISPR-edited allogeneic IL-13Ralpha2 CAR T Cells for recurrent high-grade Glioma: preclinical characterization and phase I trial. Nat Commun. 2026 Jan 6;17(1):1362. doi: 10.1038/s41467-025-68112-6.
- Background Law I, Albert NL, Arbizu J, Boellaard R, Drzezga A, Galldiks N, la Fougere C, Langen KJ, Lopci E, Lowe V, McConathy J, Quick HH, Sattler B, Schuster DM, Tonn JC, Weller M. Joint EANM/EANO/RANO practice guidelines/SNMMI procedure standards for imaging of gliomas using PET with radiolabelled amino acids and [18F]FDG: version 1.0. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):540-557. doi: 10.1007/s00259-018-4207-9. Epub 2018 Dec 5.
- Background Long AH, Haso WM, Shern JF, Wanhainen KM, Murgai M, Ingaramo M, Smith JP, Walker AJ, Kohler ME, Venkateshwara VR, Kaplan RN, Patterson GH, Fry TJ, Orentas RJ, Mackall CL. 4-1BB costimulation ameliorates T cell exhaustion induced by tonic signaling of chimeric antigen receptors. Nat Med. 2015 Jun;21(6):581-90. doi: 10.1038/nm.3838. Epub 2015 May 4.
- Background Portnow J, Wang D, Blanchard MS, Tran V, Alizadeh D, Starr R, Dodia R, Chiu V, Brito A, Kilpatrick J, McNamara P, Forman SJ, Badie B, Synold TW, Brown CE. Systemic Anti-PD-1 Immunotherapy Results in PD-1 Blockade on T Cells in the Cerebrospinal Fluid. JAMA Oncol. 2020 Dec 1;6(12):1947-1951. doi: 10.1001/jamaoncol.2020.4508.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody | Cell therapy | 3e+06 cells/kg | Intravenous |
| Subject | IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody | Cell therapy | 1e+07 cells/kg | Intravenous |