drugset / Trial / NCT07231081
Phase I Study of TX103 CAR-T Cells in Participants With Advanced Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a single-arm, open-label, Phase I study to evaluate the safety, tolerability, and antitumor activity of TX103 CAR-T cells in subjects with TX103-positive advanced solid tumors. The study also aims to explore the maximum tolerated dose (MTD) and determine the recommended Phase II dose (RP2D) of TX103 CAR-T cell therapy.
Timeline
- Start
- 2025-10-16
- Primary completion
- 2027-12-20
- Completion
- 2027-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TX103 | Cell therapy | 1e+08 cells | Intravenous |
| Subject | TX103 | Cell therapy | 3e+08 cells | Intravenous |
| Subject | TX103 | Cell therapy | 9e+08 cells | Intravenous |
| Subject | TX103 | Cell therapy | 2e+09 cells | Intravenous |
| Subject | TX103 | Cell therapy | 4e+09 cells | Intravenous |