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

Inclusion Criteria：

* Histologically prostate adenocarcinoma, exclusion of the initially diagnosed neuroendocrine or small-cell carcinoma.
* Subjects with metastatic castration-resistant prostate cancer (mCRPC) who have failed novel androgen-deprived therapy and docetaxel chemotherapy. The previous antitumor treatment is ≥4 weeks prior to first dose.
* The previous clinical trials is ≥30 days prior to screening; Under the circumstance of previous clinical trials≤3 months , the pre-trial drug cannot interfere the safety and efficacy of current trial judged by the investigators.
* Age ≥18 years old when signing ICF, male, weight ≥50kg.
* Screening ECOG performance status is ≤2.
* Written information consent provided prior to the initiation of study procedures with cooperation during the follow-up.

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.