drugset / Trial / NCT05430373

GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors

NCT05430373 ↗

Phase 1 Recruiting 31 enrolled Grit Biotechnology
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2022-05-23
Primary completion
2025-09-25
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject GT101 Cell therapy — —

Indications

No indication recorded.