Overview
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
Eligibility
Inclusion Criteria:
- Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol
- Malignant tumor determined by histological or cytological examination
- 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.