Advanced Solid Tumor
Conditions
Interventions
Sponsors
the First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join the research, sign the informed consent form, and be willing and able to abide by the research protocol; 2. Age 18~70 years (calculated on the day of signing informed consent); 3. Diagnosed as unresectable recurrent/metastatic advanced solid tumor; 4. The disease has progressed after at least one pre-sequence standard treatment; and there is no effective treatment option available (for effective treatment, please refer to the latest edition of the diagnosis and treatment guidelines for various cancer types); 5. At least one lesion (preferably superficial lymph node) that has not received radiotherapy or other local therapy, and can obtain tumor tissue, and at least a tissue block with a volume of >=0.5cm3 can be isolated (a single lesion source can be obtained). or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes; minimally invasive treatment as possible; 6. After tumor sampling, there is at least one measurable lesion that meets the definition of RECIST v1.1 criteria, and that lesion has not received radiotherapy or other local therapy (unless these therapy occurred more than 3 months ago, and the lesion showed progress); 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 8. Expected survival time >= 12 weeks; 9. The functions of vital organs meet the following requirements (no blood components and cell growth factor treatment are allowed within 14 days before surgery): Routine blood examination: Absolute neutrophil count (ANC) >= 1.5x10^9/L; Cell count (LC)>= 0.5x10^9/L; Platelet count (PLT) >= 80x10^9/L; Hemoglobin (Hb)>= 90g/L; Liver function test: AST, ALT and alkaline phosphatase = 45 mL/min (Cockcroft-Gault formula can be used) , or serum creatinine is within the normal range; coagulation function test: APTT = 50%; pulmonary function test: FEV1 >= 60%; 10. Non-surgical sterilization females of childbearing age need to agree to use at least one medically approved contraceptive method (such as an intrauterine device, contraceptives or condoms) for contraception during the study treatment period and within 1 year after the end of the study treatment period; Non-surgical sterilized female subjects of childbearing age must have a negative serum HCG test within 7 days before cell reinfusion; 11. Before tumor sampling, the adverse reactions caused by previous treatment have recovered (CTCAE 5.0 <= 1) or can meet the test values ??specified in the test protocol (except for 2nd degree peripheral neuropathy, hair loss, skin vitiligo/hormone replacement therapy controllable) Hypothyroidism and well-insulin-controlled type 1 diabetes); ensure asymptomatic status for 6 months prior to tumor sampling if documented grade 2 or higher diarrhea or colitis on prior immune checkpoint inhibitor therapy ( or safe as assessed by colonoscopy); 12. Prior to tumor sampling, there must be imaging documentation of disease progression after the last treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with active central nervous system (CNS) metastasis (patients with stable brain metastases, no need for drug treatment within 2 weeks of clinical judgment, except for those without hormone dependence); 2. Surgery and/or radiotherapy fails to relieve spinal cord compression and cannot be included in the group (patients who have been treated can be enrolled if clinical evidence shows that their symptoms have been relieved for >=1 week before surgical sampling); 3. Patients with uncontrolled tumor-related pain as judged by the investigator. Subjects requiring pain medication must have a stable analgesic regimen at the time of entry into the study; symptomatic lesions suitable for palliative radiotherapy should be treated prior to study entry; 4. Suffering from interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory diseases that seriously affect lung function; 5. Any active autoimmune disease, history of autoimmune disease, or disease requiring systemic steroids or immunosuppressive drugs (>10 mg/day of prednisone or equivalent hormones); 6. Those who have active pulmonary tuberculosis infection within 1 year before enrollment, or those who have a history of active pulmonary tuberculosis infection more than 1 year ago but have not received regular treatment; 7. Active infections requiring systemic anti-infective treatment (except for topical antibiotics) or those with unexplained fever > 38.5 degree C during the screening period, except for tumor fever; 8. Have a history of immunodeficiency, including HIV seropositive; 9. Active hepatitis B or C patients. HBsAg or HBcAb positive patients can participate in this study if the HBV DNA test is less than the lower limit of the normal value in the research center. HCV antibody-positive patients can participate in this study if the HCV RNA detection is less than the lower limit of the normal value detected by the research center. Carriers participating in the study should arrange antiviral treatment as appropriate, and conduct regular review during the study period for quantitative nucleic acid copy number detection; 10. There are intractable or intractable epilepsy, massive ascites, active gastrointestinal bleeding and other contraindications to the use of IL-2; 11. Use of live attenuated vaccines within 4 weeks before enrollment, or use of live attenuated vaccines during the study period; 12. Use anti-angiogenic drugs with long half-life, such as VEGF bevacizumab, within the first four weeks of enrollment; 13. Patients who have received allogeneic bone marrow transplantation or solid organ transplantation in the past; 14. 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) history of allergic reaction to any component of , dextran-40 (dextran-40), antibiotics (beta-lactam antibiotics, gentamicin)); 15. Known mental illness, alcoholism, drug use or drug abuse; 16. Any disease or condition (any other disease, metabolic disorder, abnormal physical examination or laboratory test results) that could cause reasonable suspicion to prohibit the use of the investigational drug, or affect the interpretation of study results, or put the patient at high risk for complications of treatment result); 17. Lactating women; 18. Other investigators assess situations that may affect the safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate ;Disease control rate ;Progression free survival ;Response period;Overall survival; | — |
Countries
China
Contacts
Public ContactChen Weichang
the First Affiliated Hospital of Suzhou University
Outcome results
None listed