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

NCT05430360 | Terminated Phase 1

• 1 other identifier: GRIT-CO-FA-018
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adcersed events per CTCAE 5.0

  To characterize the safety profile of autologous TIL injection（GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0

  3 years

Secondary Outcomes (3)

• Objective response rate

  3 years

• Progression-free survival

  3 years

• Overall survival

  3 years

Study Arms (1)

GT201 treatment group

EXPERIMENTAL

Autologous tumor infiltrating lymphocyte injection

Biological: GT201

Interventions

GT201 BIOLOGICAL

Autologous tumor infiltrating lymphocyte injection

GT201 treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol
• 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
• Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

You may not qualify if:

• Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment
• People with uncontrolled tumor-related pain as judged by the investigator
• Risk of major bleeding as assessed by investigators
• Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function
• 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));
• ：Women who are pregnant or breastfeeding; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year of the cell return.

Sponsors & Collaborators

• Grit Biotechnology: lead

Study Sites (1)

The First Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2022
• First Posted: June 24, 2022
• Study Start: January 4, 2022
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)