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

NCT05724732 | Unknown Early Phase 1

• 1 other identifier: GRIT-CD-MED-CHN-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Safety Profile Measured by Grade ≥3 TEAEs

  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)

  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: female
• 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.
• 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.
• 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. 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.
• 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 .
• 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;

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Central Study Contacts

Wen Di, PhD

CONTACT

+86 13701642665; diwen163@163.com

Study Design

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

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 13, 2023
• Study Start: February 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)