drugset / Trial / NCT05933668
Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Solid Tumor
Phase 1
Not yet recruiting
11 enrolled
Peking University
Yingkai Saiwei（Beijing）Biotechnology Co., Ltd · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a single center, open, single arm, dose increasing early clinical study. The purpose of this study is to evaluate the safety and efficacy of YK0901 immunotherapy in the treatment of patients with advanced solid tumor whose tumor antigen KRAS G12V expression is positive (HLA-A \* 11:01).
Timeline
- Start
- 2023-07
- Primary completion
- 2024-07
- Completion
- 2026-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | YK0901 cells | Cell therapy | 1e+08 cells | — |
| Subject | YK0901 cells | Cell therapy | 1e+09 cells | — |
| Subject | YK0901 cells | Cell therapy | 5e+09 cells | — |
| Subject | YK0901 cells | Cell therapy | 2e+10 cells | — |
| Subject | YK0901 cells | Cell therapy | 5e+10 cells | — |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Background | Fludarabine | Small molecule | 25 mg/m2 | — |
| Background | IL-2 | Protein / enzyme biologic | 500000 iu | Subcutaneous |
| Background | Oxaliplatin | Small molecule | 100 mg | — |