Advanced Solid Tumor
Conditions
Interventions
GT201 treatment group:TIL infusion
Sponsors
The First Affiliated hospital Zhejiang 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. Aged 18~70 years(calculated on the day of signing informed consent); 3. Diagnosed as: unresectable recurrent or metastatic advanced solid tumor; 4. The disease has progressed after the previous 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. There is at least one lesion (preferably superficial lymph node) that has not received radiotherapy or other local therapy, and tumor tissue can be obtained, and at least a tissue block with a mass of >=1.0g 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) >= 1.5 x 10^9/L; Cell count (LC) >= 0.5 x 10^9/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 been recovered (CTCAE 5.0 <= 1) or can meet the detection values ??specified in the test protocol (excluding 2nd degree peripheral neuropathy, hair loss, skin vitiligo/hormone replacement therapy controllable) hypothyroidism and well-insulin-controlled type 1 diabetes); ensure 6 months of asymptomatic status 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 analgesic 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 entry into the study; 4. In lung cancer, diagnosis of non-small cell lung cancer involving the superior sulcus, large cell neuroendocrine carcinoma, sarcomatoid tumor; head and neck tumor with necrotic foci, with major bleeding risk assessed by the investigator: high bleeding risk (examples include but Not limited to tumor encasing or infiltrating major blood vessels [ie, carotid artery, jugular vein, bronchial artery] and/or exhibiting other high-risk features such as fistula, significant cavitary lesion, prior bleeding history [10 mg/day of prednisone or equivalent hormones); 7. 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; 8. Active infection requiring systemic anti-infective treatment (except topical antibiotics) or unexplained fever >38.5 degree during screening, except tumor fever; 9. A history of immunodeficiency, including HIV seropositive; 10. 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 periodically review the nucleic acid copy number quantitative detection during the study period; 11. Patients with refractory or intractable epilepsy, ascites that cannot be controlled by drugs, portal vein tumor thrombus, gastrointestinal bleeding caused by gastric fundus or esophageal varices, increased risk of bleeding caused by portal hypertension, active gastrointestinal bleeding, etc.; 12. Patients who have received allogeneic bone marrow transplantation or solid organ transplantation in the past; 13. 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)); 14. Known mental illness, alcoholism, drug use or drug abuse; 15. Any disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate ;Objective response rate ;Progression free survival ;Response period;Overall survival; | — |
Countries
China
Contacts
Public ContactFang Weijia
The First Affiliated Hospital Zhejiang University
Outcome results
None listed