Advanced solid tumor
Conditions
Interventions
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years old; 2. Immunohistochemical (IHC) measurement of target expression in the laboratory approved by the sponsor is positive; 3. Solid tumor proved by cytology or pathology as the indication of this experimental scheme; 4. Patients who have failed or relapsed after at least the first-line and second-line standardized treatment, or patients who are intolerant or voluntarily give up the first-line and second-line standardized treatment; 5. There is at least one extracranial measurable lesion according to RECIST1.1 standard; 6. Estimated survival time >= 90 days; 7. The main organs function normally, that is, the following standards are met: (1) ECOG physical state score is 0-1 or KPS score > 70; (2) The blood routine examination standard meets the requirements: 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 dysfunction; 9. No allergy to developer; 10. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before entering the group, and the result is negative, and they are willing to use appropriate methods of contraception during the test period and 8 weeks after the last CART (women who have undergone sterilization or at least 2 years after menopause can be considered as infertile); 1. Subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Past history of other malignant tumors; 2. T cell transduction efficiency is less than 5% or T cell amplification after culture is less than 2 times; 3. Participated in clinical trials of other drugs within 4 weeks before the start of the study; 4. Patients with hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg, as judged by researchers), with myocardial ischemia or myocardial infarction above grade I, arrhythmia above grade I (including QT interval >= 440 ms) or cardiac insufficiency; 5. Long-term unhealed wounds or fractures in the chest or other parts; 6. Those who have a history of psychotropic substance abuse and can't give up or have a history of mental disorder; 7. Patients with objective evidence of past and present pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severe impairment of lung function; 8. There are fungi, bacteria, viruses or other infections that are uncontrollable or need antibiotic treatment. After consulting medical inspectors, it is allowed to have simple urinary tract infection and bacterial pharyngitis without complications; 9. According to NCI-CTCAE 4.0 standard, the subjects who had used chemotherapy in the past had hematological toxicity >= 2 or non-hematological toxicity >= 3 when they entered the group; 10. It is known that there is a history of HIV, or the nucleic acid test of hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) is positive, and the specific and non-specific antibodies of syphilis are positive; 1. There is any indwelling catheter or drainage tube (such as bile drainage tube or pleural/peritoneal/pericardial catheter). Allow the use of special central venous catheter (colostomy, percutaneous nephrostomy tube and Foley catheter in patients with intestinal cancer, which will be considered by researchers); 12. There is brain metastasis; 13. There is a history or disease of CNS, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS; 14. There is a major immunodeficiency; 15. The major therapeutic drugs in this study (including fludarabine, cyclophosphamide, mesna, toctuzumab and anti-infective drugs used during pretreatment) have a history of severe hypersensitivity; 16. There was a history of deep vein thrombosis or pulmonary embolism within 6 months before enrollment; 17. There is a history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause end organ damage or require systemic immunosuppressive/systemic disease regulating drugs in the past two years; 18. There are any diseases that may interfere with the safety or efficacy evaluation of research and treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and objective response rate (complete response [CR] + partial response [PR]) of CAR-T targeted therapy for patients with advanced gynecological tumors; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of overall response;Progression-free survival;Overall survival;Incidence of adverse events and serious adverse events;Vital signs;Serum levels of cytokines (IL-2, IL-6, TNF-a, IFN-?, etc.);Physical examination;Laboratory examination; | — |
Countries
China
Contacts
Public ContactXu Qing
Shanghai Stansai Biotechnology Co., Ltd.
Outcome results
None listed