GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

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).

NCT Number	NCT05430373
Lead Sponsor	Grit Biotechnology
Conditions	Solid Tumors, Adult
Enrollment	31 participants
Start Date	2022-05-23
Primary Completion	2025-09-25 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-14