Advanced pancreatic cancer
Conditions
Interventions
Sponsors
Tumor Hospital affiliated to Fudan 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 confirmed pancreatic cancer; 4. Patients who are ineffective or relapsed after at least standard treatment, or patients who cannot tolerate standard treatment or voluntarily give up; 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 0~1 or KPS score > 70; blood routine examination standards meet: 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); 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 (received sterilization or menopause during the experimental period and 8 weeks after the last CART administration) Women who are at least 2 years later 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; 12. The transduction efficiency of T cells is less than 5% or the expansion of T cells after culture is less than 2 times.
Exclusion criteria
Exclusion criteria: 1. Previous history of other malignant tumors; 2. Participated in clinical trials of other drugs within 4 weeks before the start of the study; 3. Patients with hypertension that cannot be well controlled by a single antihypertensive drug (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg, the specific situation is judged by the investigator), suffering from myocardial ischemia or myocardial infarction above grade I, Grade I and above arrhythmias (including QT interval >= 440ms) or cardiac insufficiency; 4. Wounds or fractures in the chest or other parts that have not healed for a long time; 5. Those who have a history of psychotropic substance abuse and cannot be abstained from or have a history of mental disorders; 6. Patients with past and current objective evidence of history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 7. Presence of a fungal, bacterial, viral or other infection that is uncontrollable or requires antibiotic treatment. Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted after consultation with a medical monitor; 8. For subjects who have used chemotherapy in the past, according to the NCI-CTCAE 4.0 criteria, there is >= grade 2 hematological toxicity at the time of enrollment, or >= grade 3 non-hematological toxicity; 9. Known history of HIV, or positive nucleic acid test for hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive), positive specific and non-specific antibodies for syphilis, or any uncontrollable active infection, including but not limited to not limited to active tuberculosis; 10. Presence of any indwelling catheters or drains (eg, bile drains or pleural/peritoneal/pericardial catheters). Allow the use of dedicated central venous catheters (fistulas, percutaneous nephrostomy tubes, and indwelling Foley catheters in patients with colorectal cancer, the investigator will consider whether it has an impact); 11. Brain metastases; 12. There is a history or disease of the CNS, such as seizure disorder, cerebral ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the CNS; 13. There is a major immunodeficiency; 14. Have a history of severe hypersensitivity reactions to the main therapeutic drugs in this study (including fludarabine, cyclophosphamide, mesna, and tocilizumab and anti-infective drugs for the prevention and treatment of CRS) used during pretreatment; 15. History of deep vein thrombosis or pulmonary embolism within 6 months before enrollment; 16. History of autoimmune diseases (eg, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that lead to end-organ damage or require systemic immunosuppressive/systemic disease-modifying drugs within the past 2 years; 17. Any disease that may interfere with the evaluation of the safety or efficacy of the study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Incidence rate of adverse events; | — |
Countries
China
Contacts
Public ContactYu Xianyuan
Tumor Hospital affiliated to Fudan University
Outcome results
None listed