drugset / Trial / NCT02208362
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Phase 1
Active not recruiting
65 enrolled
City of Hope Medical Center
Food and Drug Administration (FDA) · collabNational Cancer Institute (NCI) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This phase I trial studies the side effects and best dose of genetically modified T-cell immunotherapy in treating patients with malignant glioma that has come back (recurrent) or has not responded to therapy (refractory). A T cell is a type of immune cell that can recognize and kill abnormal cells in the body. T cells are taken from the patient's blood and a modified gene is placed into them in the laboratory and this may help them recognize and kill glioma cells. Genetically modified T-cells may also help the body build an immune response against the tumor cells.
Timeline
- Start
- 2015-05-18
- Primary completion
- 2021-02-08
- Completion
- 2026-06-08
Publications
- Brown CE, Hibbard JC, Alizadeh D, Blanchard MS, Natri HM, Wang D, Ostberg JR, Aguilar B, Wagner JR, Paul JA, Starr R, Wong RA, Chen W, Shulkin N, Aftabizadeh M, Filippov A, Chaudhry A, Ressler JA, Kilpatrick J, Myers-McNamara P, Chen M, Wang LD, Rockne RC, Georges J, Portnow J, Barish ME, D'Apuzzo M, Banovich NE, Forman SJ, Badie B. Locoregional delivery of IL-13Ralpha2-targeting CAR-T cells in recurrent high-grade glioma: a phase 1 trial. Nat Med. 2024 Apr;30(4):1001-1012. doi: 10.1038/s41591-024-02875-1. Epub 2024 Mar 7.
- Brown CE, Alizadeh D, Starr R, Weng L, Wagner JR, Naranjo A, Ostberg JR, Blanchard MS, Kilpatrick J, Simpson J, Kurien A, Priceman SJ, Wang X, Harshbarger TL, D'Apuzzo M, Ressler JA, Jensen MC, Barish ME, Chen M, Portnow J, Forman SJ, Badie B. Regression of Glioblastoma after Chimeric Antigen Receptor T-Cell Therapy. N Engl J Med. 2016 Dec 29;375(26):2561-9. doi: 10.1056/NEJMoa1610497.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IL13Ra2-specific CAR Tcm cells | Cell therapy | 1e+07 cells | Intrathecal |
| Subject | IL13Ra2-specific CAR Tcm cells | Cell therapy | 5e+07 cells | Intrathecal |
| Subject | IL13Ra2-specific CAR Tcm cells | Cell therapy | 1e+08 cells | Intrathecal |
| Subject | IL13Ra2-specific CAR Tn/mem cells | Cell therapy | 1e+07 cells | Intrathecal |
| Subject | IL13Ra2-specific CAR Tn/mem cells | Cell therapy | 5e+07 cells | Intrathecal |
| Subject | IL13Ra2-specific CAR Tn/mem cells | Cell therapy | 1e+08 cells | Intrathecal |