Safety of Prodencel in the Treatment of Metastatic Castration-resistant Prostate Cancer (mCRPC)

Exclusion Criteria

• •Treatment requirement of Olaparib with the confirmed BRCA gene mutation.
• •Rechallenge of docetaxel or other chemotherapy.
• •Imminent Radiotherapy with radium-223.
• •Plan to participate in other clinical trials.
• •Pathological long bone fracture (cortical erosion \> 50% on imaging) or spinal cord compression.
• •History of other malignancies in the past 5 years with the exception of the following：cancer disease free≥5 years or squamous or basal cell skin carcinoma.
• •Systemic therapy of immunosuppressive agents (such as cyclosporine, tacrolimus, rapamycin, and azathioprine, etc.) within one month prior to screening.
• •Use of oral, intramuscular or intravenous corticosteroids within 28 days prior to enrollment. Short-term use of corticosteroids are allowed to prevent reactions for imaging studies. Use of inhaled corticosteroids for breathing insufficiency (chronic obstructive pulmonary disease) and topical steroids are allowed.
• •Positive infectious disease screening. Active HBV hepatitis (defined as positive HBsAg with HBV-DNA ≥ upper limit of normal （ULN））; Active hepatitis C (defined as HBV-Ab ≥ULN)； Positive COVID-19；Human immunodeficiency virus (HIV) infection with HIV-Ab ≥ULN；Positive syphilis with TP-Ab≥ULN.
• •Myocardial infarction, unstable angina pectoris, cardiac surgery or interventional therapy within 6 months prior to enrollment. Congestive heart failure, atrial fibrillation or other poorly controlled arrhythmias.
• •Cerebrovascular events (including hemorrhagic, ischemic, transient ischemic attack), craniocerebral surgery and unexplained loss of consciousness occurred within 6 months before enrollment.
• •Presence of the malignant pleural effusion or malignant ascites.
• •History of severe allergic reactions or allergies to the ingredients of Prodencel.
• •Abnormal screening hematologic function: white blood cell count (WBC)\<3.0×109/L, neutrophil count (NEUT)\<1.5×10\^9/L, platelet count (PLT)\<100×10\^9/L, hemoglobin (Hb)\< 100g/L.
• •Abnormal screening coagulation function: prothrombin time (PT) ≥ULN, international normalized ratio (INR) ≥ULN, thrombin time (TT) ≥ULN.
• •Abnormal screening liver and kidney function: total bilirubin (TBIL) \> 1.5ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5ULN; serum creatinine (SCr) \> 1.5 ULN.
• •History of splenectomy.
• •Presence of primary or secondary immunodeficiency disease.
• •History of uncontrolled seizures, central nervous system disorders, or psychotic loss of cognition.
• •History of chronic alcohol or drug abuse within 6 months prior to screening.
• •Unstable systemic diseases, such as active infection, liver cirrhosis, chronic renal failure, severe chronic lung diseases, etc.
• •Clinically severe pericardial effusion.
• •Not suitable for leukapheresis.
• •For any other reasons, the patients are believed not suitable for participation in this study by investigators.