Prostate cancer
Conditions
Interventions
Group 1:Reactive T cell infusion
Sponsors
The First Affiliated Hospital of Wannan Medical College
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this clinical study, and sign the informed consent, good compliance, and cooperate with follow-up; 2. Aged between 50-80 years old, prostate cancer has been confirmed by prostate biopsy; 3. Pre-evaluate patients who need adjuvant ADT after radical prostatectomy or who have received ADT in the past and eventually progress to the CRPC stage, and the guideline recommends that the treatment is ineffective or intolerable; 4. Tumor tissue can be obtained by puncture or surgery (diameter not less than 0.5 cm); 5. According to the RECIST version 1.1 standard, there should be at least one extracranial measurable lesion, and patients with bone metastases can be regarded as measurable lesions if they are clearly imaged on PET CT; 6. Expected survival period >= 180 days; 7. The function of major organs is normal, that is, the following criteria are met: (1) The ECOG performance status score is 0-2; (2) The blood routine examination standards meet: HB >= 90 g/L (no blood transfusion within 14 days), WBC >= 3.5 × 10^9 /L, ANC >= 1.5 × 10^9 /L, PLT >= 80 × 10^9 /L; (3) Biochemical examination should meet the following standards: ALB >= 2.8 g/dL, TBIL = 50 ml/min; (4) Cardiac ejection Score >= 50%; 8. No bleeding disorders or coagulation disorders; 9. No allergy to developer;
Exclusion criteria
Exclusion criteria: 1.T cells expanded less than 5-fold after culture; 2. Participated in clinical trials of other drugs within 4 weeks before the start of the study; 3. Patients with high blood pressure (systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 mmHg), severe myocardial ischemia or myocardial infarction, severe arrhythmia (including QT interval >= 440 ms) or cardiac insufficiency; 4. Long-term unhealed wounds or fractures of the chest or other parts, except compression fractures; 5. Those who have a history of psychotropic substance abuse and cannot quit or have a history of mental disorders; 6. Patients with past and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.; 7. The presence of fungal, bacterial, viral or other infections that cannot be controlled or require antimicrobial treatment. If there is a response to treatment, after consulting a medical supervisor, allow the presence of simple urinary tract infection and uncomplicated bacterial pharyngitis; 8. For subjects who have previously used chemotherapy, according to NCI-CTCAE 5.0 criteria, there is >= grade 2 hematological toxicity, or >= grade 3 non-hematological toxicity; 9. Known history of HBV/ HCV/HIV or syphilis; 10. The presence of brain metastases; 11. The presence of a history or disease of the CNS, such as seizure disorders, severe dementia, cerebellar disorders, or any autoimmune disease involving the CNS, and cerebrovascular ischemia /hemorrhage is assessed by the investigator to be eligible for enrollment; 12. The presence of major immunodeficiencies; 13. A history of severe hypersensitivity reactions to the main therapeutic agents in this study (including fludarabine, cyclophosphamide, and tocilizumab used during pretreatment); 14. There was a history of deep vein thrombosis or pulmonary embolism within 6 months before admission; 15. A history of autoimmune diseases (e. g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause end organ damage or require systemic immunosuppressive /systemic disease-regulating drugs in the past 2 years; 16. Any disease that may interfere with the assessment of the safety or efficacy of the study therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prostate specific antigen;Positron Emission Tomography-Computed Tomography, PET-CT;lifetime; | — |
Countries
China
Contacts
Public ContactHuang Houbao
The First Affiliated Hospital of Wannan Medical College
Outcome results
None listed