Advanced solid tumor
Conditions
Interventions
Group 4:Select the above optimal dose for a single dose
Sponsors
The Affiliated Hospital of Nantong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) 18-70 years old, both male and female, pre-survival period is not less than 4 months; 2) Patients with advanced, locally advanced, or recurring and metastatic tumors confirmed by histology or cytology; 3) Patients who failed the previous standard treatment; patients who relapsed within 6 months of postoperative radiotherapy and chemotherapy; or patients who gave up treatment for various reasons after the first-line treatment failed; 4) Patients who carry EGFR gene mutations or have anaplastic lymphoma kinase (ALK) gene rearrangement after first-line treatment with TKIs can be included in the group; 5) Those who receive PD-1 or PD-L1 antibody treatment ineffective or who have been stopped for more than 4 weeks can be included in the group 6) At least one measurable target lesion (RECIST v1.1); 7) ECOG physical status score is 0-2 points; 8) Provide initial or recurring tumor tissue blocks and cut out at least 8 sections for staining and detection. Cell smears of pleural effusion drainage and centrifugation are sufficient for the detection of biomarkers and can also be included in the group; 9) Sufficient venous access for blood drawing and venous blood sampling, no contraindications for lymphocyte collection; 10) Routine blood test: white blood cell count (WBC) >=3x109/L, lymphocyte percentage (LY%) >=15%, hemoglobin Hbo (Hb) >=90g/L, platelet (PLT) >=60x10^9/L; 11) Liver and kidney functions: alanine aminotransferase, aspartate aminotransferase (ALT, AST) 50%; 13) Subjects voluntarily join the study, sign an informed consent form, have good compliance and cooperate with follow-up; 14) Patients receiving radiotherapy and chemotherapy at intervals of more than 4 weeks can be included in the group.
Exclusion criteria
Exclusion criteria: 1) The subjects with positive HBsAg or HBcAb and HBV DNA titer >=3x10^2 copies / L, HCV antibody positive and peripheral blood HCV RNA positive, human immunodeficiency virus (HIV) antibody positive, CMV DNA positive, syphilis positive, and so on; 2) Patients who have previously received any gene therapy; 3) Long term use of immunosuppressants is required for any reason; 4) Any serious, uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease and temporal arteritis; 5) Subjects with severe heart, lung, liver and kidney dysfunction or severe debilitating pulmonary disease; Cardiac function: Grade 3 or above according to the New York Heart Association (NYHA); liver function: child Puge grade C or above; renal function: chronic kidney disease (CKD) stage 4 or above; renal insufficiency stage III or above; pulmonary function: severe respiratory failure symptoms, involving other organs; brain function: central nervous system abnormality or consciousness disorder; uncontrolled brain metastasis; 6) Current systemic use of steroids (except for those who have recently or currently used inhaled steroids); 7) Pregnant and lactating subjects (the safety of this treatment for unborn children is unclear, and negative serum or urine pregnancy tests are required for female study participants with reproductive potential within 48 hours before injection); 8) Allergic to immunotherapy and related drugs; 9) Subjects with a history of organ transplantation or waiting for organ transplantation; 10) After evaluation, the researcher considered that the subjects were unable or unwilling to comply with the requirements of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Countries
China
Contacts
Public ContactJun Liu
Affiliated Hospital of Nantong University
Outcome results
None listed