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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05724732
Other study ID # GRIT-CD-MED-CHN-001
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
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