Advanced gastric cancer
Conditions
Interventions
Low dose level: 0.5×10^6 UCAR+ T Cells/kg
Sponsors
Zhongshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) 18-70 years old, both male and female, the pre-survival period is not less than 4 months; 2) Pathologically confirmed solid tumors (advanced gastric cancer, esophageal gastric junction cancer), after total resection of gastric cancer metastasis and recurrence, after first-line treatment fails; 3) The tumor marker claudin18.2 staining is moderately strong (++ or +++) positive; 4) There are measurable tumor lesions according to RECIST1.1; 5) The ECOG physical status score is 0-2 points; 6) Provide the initial or recurring tumor tissue block and cut out at least 8 sections for staining and detection; 7) Sufficient venous access for blood drawing and venous blood sampling, no contraindications for lymphocyte collection. 8) Routine blood test: white blood cell count (WBC) >= 3 x 10^9/L, lymphocyte percentage (LY%) >= 15%, hemoglobin Hbo (Hb) >= 90g/L, platelet (PLT) >= 60 x 10^9/L; 9) Liver and kidney functions: alanine aminotransferase, aspartate aminotransferase (ALT, AST) < 3 times the normal value, total bilirubin (TBiL) < 1.5 times the normal value, serum creatinine (SCr) < normal 1.5 times the value; 10) Subjects voluntarily join the study, sign an informed consent form, have good compliance and cooperate with follow-up; 11) Patients receiving radiotherapy and chemotherapy at intervals of more than 4 weeks can be included in the group.
Exclusion criteria
Exclusion criteria: 1) Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer test >= 3 x 10^2 copies/L; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA test positive; Syphilis test positive, or other uncured active infection; 2) The investigator has determined that the subject has clinically significant thyroid insufficiency; 3) Long-term use of immunosuppressive agents 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, Crohns disease and Temporal arteritis, etc.; 5) Subjects with severe heart, lung, liver, and kidney insufficiency or severe debilitating lung disease; heart function: grade 3 or above according to the New York Heart Association (NYHA) standard; liver function: Child-Puge classification standard 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 abnormalities or impaired consciousness; 6) Currently using steroids systemically (except for those who are using inhaled steroids recently or currently); 7) Pregnant and lactating women; 8) Allergy to immunotherapy and related drugs; 9) Subjects who have a history of organ transplantation or are waiting for organ transplantation; 10) Subjects who currently have unstable or active ulcers and gastrointestinal bleeding; 11) The largest single tumor lesion > 4cm; 12) Subjects who need anticoagulation therapy; 13) Subjects with history of organ transplantation or waiting for organ transplantation; 14) The subject has extensive metastases in the lungs and extensive metastases in the liver.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic characteristics; | — |
Countries
China
Contacts
Public ContactJianjun Xiao
Outcome results
None listed