drugset / Trial / NCT05724732

Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Gynecologic Tumors

NCT05724732 ↗

Phase 0 Unknown 24 enrolled RenJi Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study is a single-center, single-arm phase I clinical trial. A total of 24\~26 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
2023-02-01
Primary completion
2025-05-01
Completion
2025-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject GT201 Cell therapy — —

Indications