drugset / Trial / NCT04766320
Study on TIL for the Treatment of r/r Gynecologic Tumors
NaSingle-groupOpen-labelTreatment
Summary
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant refractory/relapsed gynecologic tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with fludarabine and cyclophosphamide.
Timeline
- Start
- 2021-01-04
- Primary completion
- 2022-12-04
- Completion
- 2025-01-31
Publications
- Guo J, Wang C, Luo N, Wu Y, Huang W, Zhu J, Shi W, Ding J, Ge Y, Liu C, Lu Z, Bast RC Jr, Ai G, Yang W, Wang R, Li C, Chen R, Liu S, Jin H, Zhao B, Cheng Z. IL-2-free tumor-infiltrating lymphocyte therapy with PD-1 blockade demonstrates potent efficacy in advanced gynecologic cancer. BMC Med. 2024 May 20;22(1):207. doi: 10.1186/s12916-024-03420-0.
- Guo J, Luo N, Ai G, Yang W, Zhu J, Li C, Chen R, Zhang C, Liu S, Jin H, Cheng Z. Eradicating tumor in a recurrent cervical cancer patient with autologous tumor-infiltrating lymphocytes and a modified lymphodepleting regimen. J Immunother Cancer. 2022 Feb;10(2):e003887. doi: 10.1136/jitc-2021-003887.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tumor Infiltrating Lymphocytes | Cell therapy | 1e+09 cells | Intravenous |
| Subject | Tumor Infiltrating Lymphocytes | Cell therapy | 3e+11 cells | Intravenous |