Malignant solid tumors
Conditions
Interventions
1A:Chemotherapy preconditioning + EcTIL cell
1B:Chemotherapy preconditioning + ScTIL cell
1C:Chemotherapy preconditioning + ScTIL cell + B cell booster adjuvant
2A:Chemotherapy preconditioning + ETIL cell
2B:Chemotherapy preconditioning + STIL cell
2C:Chemotherapy preconditioning + STIL cell + B cell booster adjuvant
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the clinical study and sign the informed consent form; 2. Aged >= 18 yand = 10 mm, and malignant lymph node short diameter >= 15 mm) under enhanced scanning (imaging examination within 28 days); 9. Clinical laboratory examination indexes: Hematological examination indexes: 1 Within 14 days before screening, no blood transfusion, no G-CSF treatment and no medication correction were conducted 1) Leukocyte count >= 3.5 x 10^9/ L; neutrophil count >= 1.5 x 10^9/L; lymphocyte count >= 0.8 x 10^9/L 2) Hemoglobin >= 100 g / L 3) Platelet count >= 100 x 10^9/L Biochemical indexes: 1 1) Total bilirubin (TBIL) <= 1.5 upper limits of normal (ULN) 2) AST and alt <= 3 upper limit of normal value (ULN) 3) Blood urea nitrogen (BUN), serum creatinine (CR) <= 1.5 upper limit of normal value (ULN) Note: Patients with liver metastasis or liver cancer: AST and alt <= 5 upper limit of normal value (ULN); 10. Eligible fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence, etc.) with their partners during the trial and at least 90 days after the last medication; women of childbearing age (as defined in Appendix 8) must have a negative blood or urine pregnancy test within 7 days before the first use of the study drug; 11. Be able to follow the clinical research protocol and follow-up process.
Exclusion criteria
Exclusion criteria: 1. Have received bone marrow transplantation, stem cell transplantation or organ transplantation in the past; 2. Received systemic anti-cancer treatment and systemic use of glucocorticoid within 4 weeks; 3. Participated in clinical trials of other drugs within 4 weeks; 4. They had received other vaccines within 4 weeks and were not allowed to receive other vaccines 8 weeks after the last cell transfusion; 5. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 4 weeks; 6. Received immuno-check point suppressive therapy within 3 months; 7. Received other immunotherapy (such as cell therapy) within 3 months; 8. Clinical diagnosis of active bacterial or fungal infection (>= grade 2 of NCI-CTC 3rd Edition); 9. People with HIV, syphilis or HCV or HBV infection are in the active phase of the virus; 10. Accompanied with central nervous system tumor (except glioma); 11. Subjects with definite tendency of gastrointestinal bleeding or gastrointestinal bleeding included: Patients with local active ulcer lesions and fecal occult blood (++); patients with history of melena, hematemesis and hemoptysis within 2 months; 12. Pleural or peritoneal effusion with clinical symptoms, i.e. therapeutic serous cavity puncture or drainage decompression, or Child-Pugh score > 2; 13. Patients with severe asthma who were treated with immunosuppressive drugs; 14. Patients with severe disease or adverse reaction after treatment with monoclonal antibody; 15. Severe coronary artery disease or cerebrovascular disease, or other diseases considered by the researchers as not eligible for inclusion; 16. Subjects with a history of psychotropic substance abuse and unable to quit or with mental disorders; 17. Drug abuse, clinical or psychological or social factors that affect informed consent or research implementation; 18. Patients with previous history of vaccine allergy or other potential immunotherapy allergies considered by researchers; 19. Poor compliance; 20. Pregnant or lactating women; 21. There are any clinically uncontrolled active diseases except for tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical examination;Vital signs;ECOG score;Screening for Four infectious diseases;Pregnancy test (female subjects with the possibility of pregnancy);Routine blood test;Routine urine test;Routine stool test;Blood biochemistry;Coagulation function;C-reactive protein;Cytokine quantification;Detection of lymphocyte subsets;Immunoglobulin quantification;CTC detection;ctDNA sequencing;Dynamic monitoring of E/S(c)TIL in peripheral blood;T cell receptor sequencing;Tumor tissue sequencing;12-lead ECG;Imaging examination of tumor;Adverse event;Concomitant therapy;Quality of life score;Objective Response Rate, ORR;Progress Free Survival, PFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactYi Zhang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed