drugset / Trial / NCT06482905
Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a phase I, open-Label, single/multiple dose, dose-escalation study to evaluate the safety, tolerability and antitumor activity of anti-B7-H3 CAR-T cell injection (TX103) in subjects with recurrent or progressive Grade 4 Glioma.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.
Timeline
- Start
- 2024-09-04
- Primary completion
- 2026-09
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TX103 | Cell therapy | 6e+07 cells | Intravitreal |
| Subject | TX103 | Cell therapy | 1.5e+08 cells | Intravitreal |
| Subject | TX103 | Cell therapy | 2.5e+08 cells | Intravitreal |