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

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

NCT ID: NCT05533203

Condition: Metastatic Castration-resistant Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
metastatic castration-resistant prostate cancer
dendritic cell vaccine

Study type: Interventional

Study phase: Phase 1

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Prodencel; an autologous dendritic cell therapeutic tumor vaccine
Description: Subcutaneous injection, each injection point should not exceed 1ml.
Arm group label: Prodencel Treated for mCRPC

Summary: This phase I clinical trial is to evaluate the safety of Prodencel (an autologous dendritic cell therapeutic tumor vaccine.) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Detailed description: This is a single arm pilot study to evaluate the safety of delivering a dendritic cell vaccine in fifteen to twenty-four (n=15-24) adult patients diagnosed with prostate adenocarcinoma after novel androgen-deprived therapy and docetaxel chemotherapy failure. The study is constructed in a 3+3 design for three steps of dose escalation with rigorous and mandatory safety monitoring. Subjects received the vaccine at a dose of 5-15×10^6 cells every two weeks for a total of 3 doses. A dose from cohort 1-3 is recommended for booster immunization every 4 weeks until disease progression or intolerance, to evaluate the safety and tolerability of the booster immunization of Prodencel. Subjects will be monitored for adverse events as dictated by CTCAE version 5.

Criteria for eligibility:
Criteria:
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.

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai Changhai Hospital, The First Affiliated Hospital of Naval Medical University

Address:
City: Shanghai
Zip: 200433
Country: China

Status: Recruiting

Contact:
Last name: Linhui Wang, Ph.D.

Phone: +86 13901635510
Email: wanglinhuicz@163.com

Investigator:
Last name: Linhui Wang, Ph.D.
Email: Principal Investigator

Start date: August 8, 2022

Completion date: March 1, 2024

Lead sponsor:
Agency: Shanghai Humantech Biotechnology Co. Ltd
Agency class: Industry

Collaborator:
Agency: Shanghai Changhai Hospital,The First Affiliated Hospital of Naval Medical University
Agency class: Other

Source: Shanghai Humantech Biotechnology Co. Ltd

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05533203