Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Gynecologic Tumors

Early Phase 1

Recruiting

• Conditions: Solid Tumor
• Interventions: Biological: GT201

• Registration Number: NCT05724732
• Lead Sponsor: RenJi Hospital

Brief Summary

This study is a single-center, single-arm phase I clinical trial. A total of 24\~26 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-01
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Last Update Submitted: 2023-02-01
• Study First Posted: 2023-02-13
• Last Update Posted: 2023-02-13
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• 1.Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.

  2.Patients with advanced cervical cancer, ovarian cancer, endometrial cancer and other gynecological tumors who have progressed or are intolerant to at least first-line therapy, or who are not suitable for existing first-line therapy.

  3.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.

  4.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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GT201 treatment group	GT201	Autologous tumor infiltrating lymphocyte injection

Primary Outcome Measures

Name	Time	Method
Safety Profile Measured by Grade ≥3 TEAEs	3 years	To characterize the safety profile of autologous TIL injection（GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years	To evaluate efficacy parameters such Overall Survival (OS)
Progression-free survival	3 years	To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator
Objective response rate	3 years	To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator

Trial Locations

Locations (1)

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China