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Trial Title:
Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Gynecologic Tumors
NCT ID:
NCT05724732
Condition:
Solid Tumor
Conditions: Official terms:
Genital Neoplasms, Female
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
GT201
Description:
Autologous tumor infiltrating lymphocyte injection
Arm group label:
GT201 treatment group
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
Criteria for 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;
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Wen Di, PhD
Phone:
+86 13701642665
Email:
diwen163@163.com
Start date:
February 1, 2023
Completion date:
May 1, 2025
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05724732
