Single-center, Single-arm Phase I Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/Recurrent Advanced Solid Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Incidence and severity of adcersed events per CTCAE 5.0
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year of the cell return.
Arms & Interventions
GT201 treatment group
Autologous tumor infiltrating lymphocyte injection
Intervention: GT201 (Biological)
Outcomes
Primary Outcomes
Incidence and severity of adcersed events per CTCAE 5.0
Time Frame: 3 years
To characterize the safety profile of autologous TIL injection（GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0
Secondary Outcomes
- Overall survival(3 years)
- Objective response rate(3 years)
- Progression-free survival(3 years)