drugset / Trial / NCT05430360
Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/Recurrent Advanced Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
This study is a single-center, single-arm phase I clinical trial. A total of 30 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study. An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period
Timeline
- Start
- 2022-01-04
- Primary completion
- 2025-12-30
- Completion
- 2025-12-30
Outcome
Outcome not reported
Stopped (Business): “The study was terminated from a business perspective.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GT201 | Cell therapy | — | — |