Suzhou Maximum Bio-tech Co., Ltd
Conditions
Interventions
Low dose level:????
Middle dose level:????
High dose level:????
Sponsors
Zhongshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-70 years old, both male and female, with a pre survival period of not less than 4 months; 2. Patients with histologically or cytologically confirmed advanced, locally advanced or metastatic tumors; 3. Patients who failed in previous standard treatment; patients who recurred within 6 months after operation; or patients who gave up treatment for various reasons after failure of first-line treatment; 4. Patients with EGFR gene mutation or ALK gene rearrangement who have disease progression or toxicity intolerance after first-line TKIs treatment can be enrolled; 5. Patients who failed to receive PD-1 or PD-L1 antibody treatment or stopped the treatment for more than 4 weeks can be enrolled 6. Patients with at least one measurable target lesion (RECIST v1.1); 7. Subjects with ECoG score of 0-2; 8. Provide primary or recurrent tumor tissue and cut at least 8 sections for staining and detection. If the pleural effusion drainage centrifugation cell smear is enough for the detection of biomarkers, it can also be included in the group; 9. Sufficient venous access for blood sampling and venous blood sampling, no contraindications for lymphocyte collection; 10. Routine blood examination: white blood cell count (WBC) >= 3 x 10^9 / L, lymphocyte percentage (ly%) >= 15%, hemoglobin (HB) >= 90g / L, platelet (PLT) >= 60 x 10^9 / L; 11. Liver and kidney function: alanine aminotransferase, aspartate aminotransferase (alt, AST) < 3 times of normal value, total bilirubin (TBIL) < 1.5 times of normal value, serum creatinine (SCR) < 1.5 times of normal value; 12. The expression of mesothelin antigen was more than 50%; 13. The subjects who volunteered to join the study signed the informed consent with good compliance and cooperated with the follow-up, 14. Patients who received radiotherapy and chemotherapy more than 4 weeks apart.
Exclusion criteria
Exclusion criteria: 1. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA titer in peripheral blood >= 3 x10^2 copies / L; subjects with positive hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood; subjects with positive human immunodeficiency virus (HIV); subjects with positive CMV DNA; subjects with positive syphilis; subjects with positive hepatitis C virus (HCV) antibody and HCV RNA in peripheral blood; 2. Patients who have received any gene therapy before; 3. Patients who need long-term use of immunosuppressants for any reason; 4. Patients with 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, etc; 5. Subjects with severe heart, lung, liver and renal insufficiency or severe weakened lung disease; heart function: Grade 3 or above according to the New York Heart Association (NYHA) standard; liver function: Grade C or above according to the child Puge classification standard; renal function: chronic kidney disease (CKD) stage 4 or above; renal insufficiency stage III or above; lung function: symptoms of severe respiratory failure, involving other organs Brain function: abnormality of central nervous system or disturbance of consciousness; 6. Patients who are currently using steroids (except those who have recently or are currently using inhaled steroids); 7. Pregnant and lactating subjects (the safety of this therapy for unborn children is not clear, and the study participants with reproductive potential must have negative serum or urine pregnancy test within 48 hours before injection); 8. Patients allergic to immunotherapy and related drugs; 9. Subjects with history of organ transplantation or waiting for organ transplantation; 10. After evaluation, the researcher believes that the subjects are unable or unwilling to comply with the requirements of the research protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic characteristics; | — |
Countries
China
Contacts
Public ContactJeiwen Peng
Zhongshan People's Hospital
Outcome results
None listed