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GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
Sponsor: Grit Biotechnology
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
Conditions
Interventions
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