drugset / Trial / NCT04318964
TAEST16001 in the Treatment of Soft Tissue Sarcoma
Phase 1
Unknown
12 enrolled
Sun Yat-sen University
Guangdong Xiangxue Precision Medical Technology Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is an open, single arm, dose increasing early clinical study, which is divided into two parts: "3 + 3" designed dose escalation study and extended group study. The purpose of this study is to evaluate the safety, tolerance, PK, PD characteristics, and preliminary efficacy of TAEST16001 immunotherapy in the treatment of patients with solid tumor maily containing soft tissue sarcoma whose tumor antigen NY-ESO-1 expression is positive (HLA-A \* 02:01).
Timeline
- Start
- 2020-03-19
- Primary completion
- 2022-04-15
- Completion
- 2024-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TAEST16001 cells | Cell therapy | 5e+08 cells | Intravenous |
| Subject | TAEST16001 cells | Cell therapy | 2e+09 cells | Intravenous |
| Subject | TAEST16001 cells | Cell therapy | 5e+09 cells | Intravenous |
| Subject | TAEST16001 cells | Cell therapy | 1.2e+10 cells | Intravenous |