Recruiting

A Multi-center,Single-arm Phase I/II Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors

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What is being tested

GT201

Biological
Who is being recruted

From 18 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: September 2022
See protocol details

Summary

Principal SponsorGrit Biotechnology
Study ContactZhengxiang Han, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 14, 2022

Actual date on which the first participant was enrolled.

This study is a multi-center, single-arm phase I clinical trial. A total of 26\~42 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 TitleA Multi-center,Single-arm Phase I/II Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors
NCT05729399
Principal SponsorGrit Biotechnology
Study ContactZhengxiang Han, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * 1.Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol. 2.At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. 3.Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1. Exclusion Criteria: * 1.Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment. 2.People with uncontrolled tumor-related pain as judged by the investigator. 3.Risk of major bleeding as assessed by investigators. 4.Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function. 5.Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy . 6.History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7.Women who are pregnant or breastfeeding;

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Autologous tumor infiltrating lymphocyte injection

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Recruiting

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, ChinaOpen The First Affiliated Hospital of Zhengzhou University in Google Maps
Recruiting

The First Affiliated Hospital of Soochow University

Suzhou, China
Recruiting

The First Affiliated Hospital of Soochow University

Suzhou, China
Recruiting

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China
Recruiting
4 Study Centers