solid tumor
Conditions
Interventions
low dozesgroup:CAR-T cells autoblood retransfusion
middle dozesgroup:CAR-T cells autoblood retransfusion
high dozesgroup:CAR-T cells autoblood retransfusion
Sponsors
Shanghai 10th People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria for inclusion in this study: 1. Aged 18 to 75 years when signing the informed consent; 2. Weight >40kg; 3. Patients with gastric, esophageal, lung, colorectal, ovarian and mesothelioma confirmed by pathology; 4. Patients with recurrent/refractory solid tumors who have failed the existing standard regimen; 5. According to RECIST 1.1, there was at least one measurable lesion, that is, non-lymph node lesion with long diameter =10 mm or lymph node lesion with short diameter >=15 mm according to CT or MRI cross-sectional images;The longest axial CT scan of the lesion was >=10 mm (CT scan layer thickness 1.5x10^9/L, platelet count >1.0x10^11/L, HGB >90g/L (no transfusion within two weeks), ALC >500x10^9/L; 7. Have appropriate liver and kidney functions: AST and ALT =40 mL/min; 8. PT/INR =25%), divided into three conditions: (1) tumor tissue samples with recurrence at the primary site or presence of lesions at the primary site and within 1 year were detected to be TM4SF1 or EpCAM positive by immunohistochemistry; (2) new tumor metastases in non-primary foci were detected by immunohistochemical method after biopsy for TM4SF1 or EpCAM positive; (3) the tumor remains in the primary lesion and the tumor tissue sample is more than 1 year, and the tumor tissue is confirmed to be TM4SF1 or EpCAM positive by re-biopsy immunohistochemistry; 10. Women of reproductive age (15-49 years) must undergo a pregnancy test with negative results within 7 days before the start of treatment; 11. ECOG score <=2 points; 12. Survival is expected to be no less than 12 weeks.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria shall not be included in the group: 1. Received any anti-tumor chemoradiotherapy within 4 weeks before the single blood collection; 2. Received anti-pd1 and anti-pd-l1 treatment within 12 weeks before the single blood collection; 3. History of organ transplantation; 4. Pregnant or nursing women; 5. Uncontrolled infectious diseases, such as baseline HBV DNA=2000 IU/ml, anti-hiv positive, and hcv-rna positive; 6. Other active infections with significant clinical significance; 7. Patients with other active malignant tumors within the previous 5 years, such as basal or squamous skin cancer, superficial bladder cancer, and in-situ breast cancer have been completely cured without follow-up treatment, excluding subjects; 8. Severe autoimmune diseases or immunodeficiency disease, such as the participants were diagnosed with severe autoimmune disease, long-term (more than 2 months) need systemic immune inhibitors (steroid) therapy, or had symptoms of immune-mediated disorder, including ulcerative colitis and crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE) and autoimmune vasculitis (wegener granulomatosis, for example); 9. Subjects who are allergic to immunotherapy or related drugs; 10. Organ failure; (1) heart III and IV; Or hypertension that cannot be controlled with standard treatment, a prior history of myocarditis, or a history of myocardial infarction within one year (2) liver: grade C of child-turcotte liver function grade; (3) kidney: renal failure and uremia stage; (4) lung: severe respiratory failure; Brain: those with impaired consciousness; 11. Patients with active bleeding and thrombotic diseases requiring treatment; 12. Patients with uncontrollable pleural and peritoneal effusion that require clinical management or intervention 13. T-cell tumors, such as t-cell lymphoma, etc.; 14. Subjects are being treated with systemic steroids or steroid inhalers; 15. Any mental illness, including dementia and altered mental state, may affect informed consent and related questionnaire comprehension; 16. Participated in other clinical trials within the previous 30 days; 17. Those who have been determined by the researcher to have a serious uncontrollable disease or other conditions that may affect the treatment in this study and are considered inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DFS/PFS;rate of survivors; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactXu Qing
Shanghai Tenth People's Hospital
Outcome results
None listed