Urinary system tumor
Conditions
Interventions
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Between the ages of 18 and 70 years; 2. The positive expression of the target was detected by immunohistochemistry (IHC) in Stansai laboratory; 3. Cytology or pathology proved to be a kind of urinary system tumor in the indications of this regimen; 4. At least patients who are ineffective or relapse after first-or second-line standard treatment, or who are intolerant or voluntarily give up first-or second-line standardized treatment; 5. At least one extracranial measurable lesion according to RECIST1.1 standard; 6. Estimated survival time >= 90 days; 7. The function of the main organs is normal, that is, they meet the following criteria: (1) The ECOG physical fitness score is 0:1 or the KPS score is > 70; (2) Blood routine test criteria were met: HB >= 90 g/L (no blood transfusion within 14 days), ANC >= 1.5 x 10^9/L, PLT >= 80 x 10^9/L, Alb >= 2.8 g/dL, serum lipase and amylase 50 mL/min (Cockcroft-Gault formula); (4) Cardiac ejection fraction > 55%; (5) The levels of calcium, potassium and magnesium in serum are within the standard range; 8. No hemorrhagic disease or coagulation disorder; 9. Not allergic to developer; 10. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before admission, and the results are negative and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of CART (women who have received sterilization or menopause 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. There is a history of other malignant tumors in the past; 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. Patients with hypertension who could not be well controlled with a single antihypertensive drug (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg, as judged by the researchers), suffered from grade I or above myocardial ischemia or myocardial infarction, grade I or above arrhythmias (including QT interval >= 440 ms) or cardiac insufficiency; 5. A wound or fracture of the chest or other parts that has not healed for a long time; 6. Those who have a history of psychotropic substance abuse and cannot be cured or who have a history of mental disorders; 7. Patients with past and present objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.; 8. 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; 9. According to NCI-CTCAE 4.0 criteria, patients who had previously used chemotherapy had hematological toxicity >= grade 2 or grade 3 non-hematological toxicity; 10. Known to have a history of HIV, or positive for hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) nucleic acid test; 11. 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); 12. There is a case of brain metastasis; 13. There is a history or disease of CNS, such as seizures, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS; 14. There is a major immune deficiency; 15. 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; 16. There was a history of deep venous thrombosis or pulmonary embolism within 6 months before enrollment; 17. 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 immunosuppressive/systemic disease regulatory drugs in the past 2 years; 18. Any disease that may interfere with the safety or efficacy of research treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of CAR-T targeted therapy in patients with advanced urinary tract tumors;Objective response rate (complete response [CR]+ partial response [PR]) of CAR-T targeted therapy in patients with advanced urinary tract tumors; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of overall response;Progression-free survival;Overall survival;Incidence of adverse events;Vital signs;The level of serum cytokines (IL-2, IL-6, TNF-a, IFN ?, etc.) ;Physical examination;Laboratory examination;The incidence of CRS;Incidence of serious adverse events; | — |
Countries
China
Contacts
Public ContactBi Jianbin
Shanghai Stansai Biotechnology Co., Ltd.
Outcome results
None listed