drugset / Trial / NCT05430360

Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/Recurrent Advanced Solid Tumors

NCT05430360 ↗

Phase 1 Terminated 2 enrolled Grit Biotechnology
NaSingle-groupOpen-labelTreatment

Summary

This study is a single-center, single-arm phase I clinical trial. A total of 30 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study. An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period

Timeline

Start
2022-01-04
Primary completion
2025-12-30
Completion
2025-12-30

Outcome

Outcome not reported

Stopped (Business): “The study was terminated from a business perspective.”

Drugs

EvaluationDrugModalityDoseRoute
Subject GT201 Cell therapy — —

Indications