drugset / Trial / NCT05430373
GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period. The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes: 1. Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine). 2. GT101 infusion. 3. post-infusion treatment (interleukin-2 intravenous push).
Timeline
- Start
- 2022-05-23
- Primary completion
- 2025-09-25
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GT101 | Cell therapy | — | — |
Indications
No indication recorded.