Advanced prostate cancer
Conditions
Interventions
experimental group :CARTcells
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 80 years old; 2.Target expression of >= 1 + was measured in an immunohistochemistry (IHC) approved laboratory, and patients without pathological films were also met if the test value of PAP expression in peripheral blood; 3.Pathology confirms prostate cancer; 4.Patients who cannot perform surgery or are not suitable for surgery, or patients who relapse after the operation, the existing treatment means can not even control the condition; 5.Patients with at least one extracranial measurable lesion by the RECIST 1.1 version standard, and bone metastases can be treated as measurable lesions if clearly imaging on PET CT; 6.The expected survival >= 60 days; 7.Main organs are normal, meeting the following criteria: (1)The ECOG fitness status score was 0-2; (2)Routine blood examination criteria meet: 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); 8.Heart ejection fraction was > 55%; 9.There was no hemorrhagic disease or coagulation dysfunction; 10.No allergic to developer; 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 systolic pressure> 40 mmHg, diastolic> 90 mmHg, was judged by the investigator) with myocardial ischemia or myocardial infarction, 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).Use special central venous catheter, catheter catheter; 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 fludalabine, cyclophosphoramide, sodium MS, and tozumab and antiinfections 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
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; | — |
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];Progression-free survival; | — |
Countries
China
Contacts
Public ContactQin Huanlong, Xu Qing
Shanghai Tenth People's Hospital
Outcome results
None listed