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

Solid Tumor Clinical Trial

Official title:

A Single-center, Single-arm Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Advanced Gynecologic Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724732
• Other study ID #: GRIT-CD-MED-CHN-001
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: February 2023
• Source: RenJi Hospital
• Contact: Wen Di, PhD
• Phone: +86 13701642665
• Email: diwen163[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Genital Neoplasms, Female
• Solid Tumor

Intervention

Biological:
• GT201
Autologous tumor infiltrating lymphocyte injection

Locations

Country	Name	City	State
China	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective response rate	To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator	3 years
Secondary	Progression-free survival	To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator	3 years
Secondary	Overall survival	To evaluate efficacy parameters such Overall Survival (OS)	3 years