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RECRUITING
NCT05430373
PHASE1

GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

Sponsor: Grit Biotechnology

View on ClinicalTrials.gov

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).

Official title: A Single-arm Phase I Clinical Study of GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2022-05-23

Completion Date

2025-12-31

Last Updated

2025-02-07

Healthy Volunteers

No

Interventions

BIOLOGICAL

GT101

Autologous tumor infiltrating lymphocyte injection

Locations (5)

The fifth medical center of the General Hospital of the Chinese people's Liberation Army

Beijing, Beijing Municipality, China

Chongqing University Cancer Center

Chongqing, Chongqing Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

West China School of Medicine/West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China