A Phase 1 Study of Autologous Dendritic Cell Immunotherapy in Patients With mCRPC

Cellgram-DC-PC is an autologous dendritic cell-based cancer immunotherapy developed for patients with metastatic castration-resistant prostate cancer (mCRPC). This was a Phase 1, single-center, open-label clinical trial designed to characterize the safety profile of Cellgram-DC-PC following administration in patients with mCRPC.

Inclusion criteria

• 19 and under 80 years
• Histologically confirmed prostate adenocarcinoma
• Patients with stage M1a or M1b with extrapelvic lymph nodes and bone metastases
• Patients diagnosed with castration-resistant prostate cancer after failure of male hormone deprivation therapy (Castrate levels of testosterone <50 ng/dL) and If either a or b is satisfied:

• Biochemical progression: Prostate Specific Antigen (PSA) increases three times in a row at 1 week intervals, two 50% increases compared to the lowest point, PSA> 2ng/mL, or
• Radiological progression: appearance of new lesions; 2 or more new lesions on the bone scan
• Asymptomatic or mild patients after previous treatment

• Patients who have not used narcotic analgesics within 21 days prior to enrollment
• Patients with an average weekly pain of less than 4 on the Visual Analogue Scale(VAS) (out of 10)
• Combination of Luteinizing hormone-releasing hormone(LHRH) analogs (leuprolide (Lupron, Viadur, Eligard) and goserelin (Zoladex, etc.) for the inhibition of gonadotropin is allowed
• Whole body performance status: European Cooperative Oncology Group(ECOG) 0~1
• Patients whose life expectancy is at least 6 months or longer
• Hb ≥ 8.0g/dL, Absolute Neutrophil Count(ANC) ≥ 1,500/mm3, Platelets ≥ 100,000/mm3
• Serum Creatinine ≤ 2.0 x Upper Limit of Normal(ULN) or Calculated Creatinine Clearance > 30mL/min
• Total Bilirubin ≤ 1.5 x ULN or Direct bilirubin ≤ ULN, Aminotransferase (AST)/Alanine aminotransferase(ALT) <2.5 x ULN
• Patients who did not receive surgery, radiation therapy, or immunotherapy within the last 6 weeks and recovered from side effects
• Patients who agreed to use medically recognized contraceptive methods during the clinical trial participation period
• Patients who voluntarily participated in clinical trials and signed the Informed Contents Form (ICF)

Exclusion criteria

• Patients who have a local recurrence and are scheduled for local treatment.
• Patients with malignant tumors other than non-melanoma skin cancer in the past 3 years
• Patients with visceral metastases (metastases to the lungs, liver, adrenal glands, peritoneum, brain, etc.)
• Patients who previously received anti-tumor immunotherapy (anti-PD1, anti-PDL1 or anti-PDL2, etc.) or participated in immunotherapy-related clinical trials
• Patients with active autoimmune diseases requiring systemic immunosuppression treatment (e.g., immunosuppressants such as cyclosporin A or azathioprine or steroids for disease control)
• Patients with medical conditions requiring continuous or intermittent administration of systemic steroids or immunosuppressants
• Patients who received blood products (limited to whole blood products) within 4 weeks of screening criteria, or patients who received colony stimulating factors (Colony Stimulating Factor or recombinant Erythropoietin)
• Patients with a history of organ or hematopoietic stem cell transplantation
• Patients with acute or chronic infections requiring systemic treatment
• Patients known to be infected with human immunodeficiency virus (HIV)/serum positive
• Patients with active hepatitis A, B or C
• Patients with untreated syphilis (Fluorescent Treponemal Antibody Absorption Test (FTA-ABS) Immunoglobulin M positive patients)
• Patients expected to require therapeutic biotherapy or immunotherapy
• Patients who received live virus vaccines (e.g. measles, mumps, rubella, chickenpox, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), oral typhoid vaccine, Flu-Mist, etc.) within 30 days
• Patients with a history of anaphylaxis to gentamicin
• Others, if the person in charge of the study determines that it is not suitable for the clinical trial