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

Primary Purpose

Solid Tumor

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
GT201
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GT201 treatment group

Arm Description

Autologous tumor infiltrating lymphocyte injection

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
February 1, 2023
Last Updated
February 1, 2023
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05724732
Brief Title
Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Gynecologic Tumors
Official Title
A Single-center, Single-arm Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Advanced Gynecologic Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GT201 treatment group
Arm Type
Experimental
Arm Description
Autologous tumor infiltrating lymphocyte injection
Intervention Type
Biological
Intervention Name(s)
GT201
Intervention Description
Autologous tumor infiltrating lymphocyte injection
Primary Outcome Measure Information:
Title
Safety Profile Measured by Grade ≥3 TEAEs
Description
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)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Objective response rate
Description
To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
Time Frame
3 years
Title
Progression-free survival
Description
To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator
Time Frame
3 years
Title
Overall survival
Description
To evaluate efficacy parameters such Overall Survival (OS)
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Di, PhD
Phone
+86 13701642665
Email
diwen163@163.com
Facility Information:
Facility Name
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Di, PhD
Phone
+86 13701642665
Email
diwen163@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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