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

NCT04615845 | Terminated Phase 1

• 1 other identifier: PMC-DC-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial was to evaluate the safety of Cellgram-DC-PC, an autologous dendritic cell-based cancer immunotherapy, in patients with metastatic castration-resistant prostate cancer (mCRPC).

Conditions

Metastatic Castration Resistant Prostate Cancer

Keywords

Metastatic Castration-Resistant Prostate Cancer; mCRPC; Autologous Dendritic Cell; Cancer Immunotherapy; Cellgram-DC-PC; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse Event

  Adverse events (AEs) were assessed for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

  From informed consent to the end of treatment at Week 28.

Secondary Outcomes (2)

• Immune Response

  At baseline (Week 0), Week 4, Week 8, Week 16, and Week 28.

• Change in Prostate-Specific Antigen (PSA)

  At baseline (Week 0), Week 2, Week 4, Week 8, Week 16, and Week 28.

Study Arms (1)

Cellgram-DC-PC

EXPERIMENTAL

Participants received Cellgram-DC-PC by subcutaneous injection near the inguinal lymph nodes.

Biological: Cellgram-DC-PC

Interventions

Cellgram-DC-PC BIOLOGICAL

Patients received three subcutaneous injections of Cellgram-DC-PC (autologous dendritic cells) near the inguinal lymph nodes at Weeks 0, 2, and 4.

Also known as: Autologous dendritic cell anti-cancer immune cell therapy for prostate cancer treatment

Cellgram-DC-PC

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (1)

Asan medical center

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• BUMJIN LIM, Ph.D

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This was an open-label study in which both investigators and participants were aware of the assigned intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants received Cellgram-DC-PC in a single-group, open-label study.

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 4, 2020
• Study Start: July 5, 2021
• Primary Completion: February 15, 2022
• Study Completion: June 30, 2022
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)