Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/Recurr… (NCT05430360) | Clinical Trial Compass
TerminatedPhase 1
Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/Recurrent Advanced Solid Tumors
Stopped: The study was terminated from a business perspective.
China2 participantsStarted 2022-01-04
Plain-language summary
This study is a single-center, single-arm phase I clinical trial. A total of 30 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
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol
✓. 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.
Exclusion criteria
✕. 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
✕. Risk of major bleeding as assessed by investigators
✕. Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function
✕
What they're measuring
1
Incidence and severity of adcersed events per CTCAE 5.0
. 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));