Advanced solid tumor
Conditions
Interventions
Sponsors
the First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2. Positive expression of the target detected by immunohistochemistry (IHC) in a laboratory accredited by the sponsor; 3. Cytological or pathological confirmation of a solid tumor in the indications of this protocol; 4. Patients who are ineffective or relapsed after at least one or two-line standard treatment, or patients who are intolerant or voluntarily give up for first- and second-line standard treatment; 5. At least one extracranial measurable lesion according to RECIST1.1; 6. Expected survival period >= 90 days; 7. The function of major organs is normal, that is, the following criteria are met: ECOG performance status score is 0-2 or KPS score > 70; blood routine examination standards meet: HB >= 90g/L, ANC >= 1.5 x 10^9/L, PLT >= 80 x 10^9/L, Alb >= 2.8g/dL, serum lipase and amylase 50 ml/min (Cockcroft-Gault formula); cardiac ejection fraction > 55%; serum calcium , potassium and magnesium levels are within the standard range; 8. No bleeding disorders or coagulation disorders; 9. No allergy to developer; 10. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and are willing to use appropriate methods of contraception during the experiment and 1 year after the last CAR-T cell infusion (acceptance). women who have been sterilized or who have been postmenopausal for at least 2 years can be considered infertile); 11. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous history of other malignant tumors (except papillary thyroid adenocarcinoma, skin and breast carcinoma in situ). 2. T cell transduction efficiency is less than 5% or T cell expansion is less than 2 times after culture. 3. Participated in clinical trials of other drugs within 4 weeks before the start of the study. 4. A wound or fracture of the chest or other parts that has not healed for a long time. 5. Those who have a history of psychotropic substance abuse and cannot be cured or who have a history of mental disorders. 6. Patients with past and present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc. 7. There are fungi, bacteria, viruses or other infections that are uncontrollable or require antibiotic treatment. After consultation with medical inspectors, simple urinary tract infections and bacterial pharyngitis without complications are allowed. 8. According to NCI-CTCAE 4.0criteria, patients who had previously used chemotherapy had hematological toxicity > =grade 2 or grade 3 non-hematological toxicity. 9. Known history of HIV; or hepatitis B (HBsAg positive); or hepatitis C virus (anti HCV positive) nucleic acid test positive. 10. There is any indwelling catheter or drainage tube (for example, bile drainage tube or pleura / peritoneum / pericardial catheter). Special central venous catheters are allowed (colostomy, percutaneous nephrostomy, and indwelling Foley catheters in patients with colorectal cancer will be considered by the researchers). 11. There is brain metastasis (except if it is stable after radiotherapy or other means). twelve There is a history or disease of CNS, such as seizures, cerebral ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS. 13. There is a major immune deficiency. 14. There was a history of severe hypersensitivity to the main therapeutic drugs in this study, including fludarabine, cyclophosphamide, meisodium, trozumab and anti-infective drugs used during pretreatment. 15. There was a history of deep venous thrombosis or pulmonary embolism within 6 months before enrollment. 16. There has been a history of autoimmune diseases (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause terminal organ damage or require systemic immunosuppression / systemic disease regulatory drugs in the past 2 years. 17. Any disease that may interfere with the safety or efficacy of research treatment. 18. Other researchers believe that the factors that do not meet the criteria for joining the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PET CT; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Public ContactZhang Yi
the First Affiliated Hospital of Zhengzhou University
Outcome results
None listed