Melanoma, lung cancer, breast cancer, cervical cancer, ovarian cancer, bladder cancer, synovial sarcoma, head and neck cancer, esophageal and gastric junction cancer
Conditions
Interventions
Experimental group :CART cells
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18-70 years; 2. Positive target expression was determined in immunohistochemistry (IHC) in a laboratory approved by the sponsor; 3. Cytology or pathology was confirmed as a solid tumor in the indications for this test protocol; 4. Patients who have failed or relapsed after at least the first or second line standard treatment, or for patients who do not tolerate or voluntarily abandon the first or second line standardized treatment; 5. At least one extracranial measurable lesion according to RECIST1.1 criteria; 6. The expected survival >= 60 days; 7. Main organs are normal, meeting the following criteria: (1) The ECOG fitness status score was 0~1 or the KPS score > 70; (2) Routine blood examination criteria met: no blood transfusion within HB >= 90g/L (14 days), 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); (4) Heart ejection fraction was > 55%; (5) Serum levels of calcium, potassium, and magnesium are within the standard range; 8. There was no hemorrhagic disease or coagulation dysfunction; 9. No allergic to developer; 10. Women of childbearing age must perform pregnancy experiments (serum or urine) within 7 days before enrollment and are willing to adopt appropriate methods during the experiment and 8 weeks after the last CART administration (women with at least 2 years after sterilization or menopause may be identified as not fertile); 11. Subjects volunteered for the study, signed informed consent, had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1.Previous history of other malignant tumors; 2.T cell transduction efficiency is 140 mmHg, diastolic> 90 mmHg, was judged by the investigator) with myocardial ischemia or myocardial infarction, arrhythmia grade I or above (including QT interval >= 440ms) or cardiac insufficiency; 5.Wound or fracture of the long-term unhealed chest or other parts; 6.Persons with a history of psychotropic substance abuse and who cannot be removed or with a history of mental disorders; 7.Patients with previous and present objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe impaired lung function, etc.; 8.There are fungi, bacteria, viruses, or other infections that are uncontrollable or require antibiotic treatment.After consulting a medical supervisor, simple urinary tract infection and complication bacterial pharyngitis are allowed; 9.For subjects who had previously used chemotherapy, with >= grade 2 hematologic toxicity or >= 3 nonhematologic toxicity according to NCI-CTCAE 4.0 criteria; 10.A history of HIV is known, or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) tested positive for nucleic acid; 11.There is any lien catheter or drainage tube (e. g., bile drainage tube or pleural / peritoneal / pericardial catheter).Special central venous catheter is permitted; 12.There of brain metastasis; 13.There is a history or disease of CNS, such as seizure disease, cerebral ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS; 14.Major immunodefects exist; 15.The main therapeutic drugs in this study (including fludarabine, cyclophosphoramide, sodium MS, and tozumab and antiinfections used against CRS) had a history of severe hypersensitivity; 16.A history of deep vein thrombosis or pulmonary embolism within 6 months before entry; 17.A history of autoimmune diseases (e. g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause end organ damage or require systemic immunosuppression / systemic disease regulatory drugs over the past 2 years; 18.There are any diseases that may interfere with the safety or efficacy assessment of the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and objective remission rate of CAR-T targeted therapy in patients with advanced urinary tract tumors (complete remission [CR] + partial remission [PR]; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of overall response;Progression-free survival;Overall survival;Incidence of adverse events and serious adverse events;Vital signs, physical examination, laboratory examination;The level of serum cytokines (IL-2, IL-6, TNF- a, IFN ?, etc.) and the incidence of CRS; | — |
Countries
China
Contacts
Public ContactQin Huanlong, Xu Qing
Shanghai Tenth People's Hospital
Outcome results
None listed