Autologous Immune Cell Therapy in Combination With LHRH-a in Patients With mCRPC

This is an interventional treatment trial for Metastatic Castration-resistant Prostate Cancer focused on measuring central memory T cell, metastatic castration-resistant prostate cancer Read More

Inclusion Criteria:

• Males age ≥ 18 years；
• Subjects who understand and sign the consent form for this study；
• Metastatic， castrate resistant, histologically confirmed prostate cancer；
• PSA> 5ng / ml；
• Serum testosterone ≤ 17nmol / L (50ng / dl)；
• Expected survival time of at least 24 months；
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
• Subjects did not receive chemotherapy, radiation therapy, surgery and other treatment within 4 weeks；

Exclusion Criteria:

• The subject has an allergic history of medicine or food；
• The patient with more serious heart disease, including but not limited to myocardial infarction, cardiomyopathy, valvular disease, malignant arrhythmia；
• Hb <9.0 g / 100ml, WBC <3 ×10^9/ L, LY <1.0 x10^9/ L, platelet <100,000 / mm3；
• Patients with immune disease or auto-immune disease (such as Multiple sclerosis, systemic lupus erythematosus，rheumatoid arthritis and inflammatory bowel disease, vitiligo )；
• The subject has uncontrolled or hard-to-control diseases of liver, or kidney system；
• Patient with visceral metastases, pathological fractures, spinal cord compression symptoms；
• Severe pain associated with bone metastases (VAS score ≧ 4 points)；
• Patient has received immunotherapy (including but not limited to PD-1 / PDL-1, etc.)；
• patient with irregular hemorrhagic disease；
• Subject is HIV, hepatitis B virus, hepatitis C virus, Treponema pallidum infection；
• Subject has uncontrollable seizures, or because of mental loss of self-knowledge and so on；
• The subject has an history of other malignant tumor；
• The patient had drug abuse, drug abuse, and long history of alcoholism in the 12 years prior to this trial；
• The subject has participated in any other clinical trial in the 3 months prior to this trial；
• The subject has any other unsuitable or adverse condition to be determined by the investigator.