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Brief Title: GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
Official Title: A Single-arm Phase I Clinical Study of GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
Study ID: NCT05430373
Brief Summary: This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, clear lung pretreatment 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The fifth medical center of the General Hospital of the Chinese people's Liberation Army, Beijing, Beijing, China
Chongqing University Cancer Center, Chongqing, Chongqing, China
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China
West China School of Medicine/West China Hospital of Sichuan University, Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, Tianjin, China