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RECRUITING
NCT05430360
PHASE1

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

Sponsor: Grit Biotechnology

View on ClinicalTrials.gov

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

Official title: Single-center, Single-arm Phase I Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/recurrent Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-01-04

Completion Date

2025-05

Last Updated

2025-02-17

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

GT201

Autologous tumor infiltrating lymphocyte injection

Locations (1)

The First Hospital of Zhejiang University

Hangzhou, Zhejiang, China