Advanced malignant solid tumor
Conditions
Interventions
Sponsors
Yantai Yuhuangding hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years; 2. The target expression was positive by immunohistochemistry (IHC) in the laboratory recognized by the research cooperation unit; 3. Cytology or pathology confirmed that it was a solid tumor in the indications of this test scheme; 4. Patients who failed or relapsed after standard regimen treatment; 5. At least one extracranial measurable lesion according to recist1.1; 6. Estimated survival = 90 days; 7. If the main organs function normally, they meet the following standards: 1) ECoG physical fitness score is 0 ~ 1 or KPS score is > 70; 2) The blood routine examination criteria are: HB = 90g / L (no blood transfusion within 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) Cardiac ejection fraction > 55%; 5) The levels of calcium, potassium and magnesium in serum were within the standard range; 8. No hemorrhagic disease or coagulation dysfunction; 9. No allergy to developer; 10. Women of childbearing age must carry out pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate contraceptive methods during the experiment and 8 weeks after the last cart (women who have received sterilization or at least 2 years after menopause can be considered as 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 medical history of other malignant tumors; 2. The T cell transduction efficiency is less than 5% or the expansion of T cells 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. People with hypertension who cannot be well controlled by a single antihypertensive drug (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg, the specific situation shall be judged by the investigator), with myocardial ischemia or myocardial infarction above grade I, arrhythmia above grade I (including QT interval = 440 ms) or cardiac insufficiency; 5. Wounds or fractures of the chest or other parts that have not been healed for a long time; 6. Those who have a history of abuse of psychotropic substances and cannot quit or have a history of mental disorders; 7. Patients with past and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of pulmonary function; 8. Fungus, bacteria, viruses or other infections that are uncontrollable or require antibiotic treatment. After consulting the medical supervisor, simple urinary tract infection and uncomplicated bacterial pharyngitis are allowed; 9. For subjects who have used chemotherapy before, according to NCI-CTCAE 4.0 standard, there was >= grade 2 hematological toxicity or >= grade 3 non hematological toxicity at the time of enrollment; 10. There is a known history of HIV, or hepatitis B (HBsAg positive) or hepatitis C virus (anti HCV positive) nucleic acid test is positive; (except for patients with liver cancer) 11. There is any indwelling catheter or drainage tube (such as bile drainage tube or pleural/peritoneal/pericardial catheter). It is allowed to use special central venous catheter (the researcher shall consider whether there is any influence on the fistula, percutaneous nephrostomy tube and retained Foley catheter of colon cancer patients); 12. 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 immune deficiency; 15. Have a history of severe hypersensitivity to the main therapeutic drugs in this study (including fludarabine, cyclophosphamide, sodium mesilate used during pretreatment, and tozumab and anti infective drugs used to prevent CRS); 16. There was a history of deep vein thrombosis or pulmonary embolism 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/disease regulating drugs in the past 2 years; 18. Any disease that may interfere with the safety or efficacy evaluation 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 ContactSongYiPeng
Shanghai stansai Biotechnology Co., Ltd
Outcome results
None listed