drugset / Trial / NCT05798533
Neo-T in Treating Patients With Advanced Solid Tumors(GI-NeoT-03)
Phase 1
Unknown
6 enrolled
BGI, China
Fudan University · collabShanghai 10th People's Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the safety of Neo-T in combination with anti-PD1 in patients with solid tumors. The secondary objective of this study is to evaluate preliminarily the effect of Neo-T in combination with anti-PD1 in patients with solid tumors.
Timeline
- Start
- 2023-01-10
- Primary completion
- 2023-09
- Completion
- 2024-09
Publications
- Background Li D, Chen C, Li J, Yue J, Ding Y, Wang H, Liang Z, Zhang L, Qiu S, Liu G, Gao Y, Huang Y, Li D, Zhang R, Liu W, Wen X, Li B, Zhang X, Zhang X, Xu RH. A pilot study of lymphodepletion intensity for peripheral blood mononuclear cell-derived neoantigen-specific CD8 + T cell therapy in patients with advanced solid tumors. Nat Commun. 2023 Jun 10;14(1):3447. doi: 10.1038/s41467-023-39225-7.
- Background Guo Z, Yuan Y, Chen C, Lin J, Ma Q, Liu G, Gao Y, Huang Y, Chen L, Chen LZ, Huang YF, Wang H, Li B, Chen Y, Zhang X. Durable complete response to neoantigen-loaded dendritic-cell vaccine following anti-PD-1 therapy in metastatic gastric cancer. NPJ Precis Oncol. 2022 Jun 3;6(1):34. doi: 10.1038/s41698-022-00279-3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NEOTETRAZOLIUM | Cell therapy | 1.2e+09 cells | Intravenous |
| Subject | NEOTETRAZOLIUM | Cell therapy | 3.6e+09 cells | Intravenous |
| Background | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Toripalimab | Monoclonal antibody | 3 mg/kg | Intravenous |