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Metastatic Castration Resistant Prostate CancerPhase 1NCT04615845

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

A Phase 1 study testing Cellgram-DC-PC in people with Metastatic Castration Resistant Prostate Cancer, run by Pharmicell Co., Ltd. at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 19 to 79 years, men only
What is being tested?
Cellgram-DC-PC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteSouth Korea
Study dates
5 Jul 2021to 30 Jun 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 79 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan medical center

    Seoul

Other trials in South Korea

About this study

Official title: An Open Label, Single-center, Phase 1 Study to Evaluate the Safety of Cancer Immunotherapy With Autologous Dendritic Cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

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).

Read the detailed description

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.

Being tested
Cellgram-DC-PC
Keywords
Metastatic Castration-Resistant Prostate Cancer, mCRPC, Autologous Dendritic Cell, Cancer Immunotherapy, Cellgram-DC-PC, Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cellgram-DC-PCBiological

    Also called Autologous dendritic cell anti-cancer immune cell therapy for prostate cancer treatment

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

Study groups in NCT04615845
Study groupRoleWhat they receive
Cellgram-DC-PCExperimentalParticipants received Cellgram-DC-PC by subcutaneous injection near the inguinal lymph nodes.
Receives: Biological: Cellgram-DC-PC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Event

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

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

Secondary outcomes (2)

  1. Immune Response

    Tumor antigen-specific immune responses were evaluated by measuring changes in serum IFN-γ and IL-12 levels and antigen-specific T-cell responses following administration of the investigational product.

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

  2. Change in Prostate-Specific Antigen (PSA)

    Exploratory efficacy was evaluated by measuring changes in prostate-specific antigen (PSA) levels from pre-treatment (Week 0) to post-treatment assessment.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2020
  2. Study start5 Jul 2021
  3. Primary completion15 Feb 2022
  4. Study completion30 Jun 2022

Why it stopped: Difficulties in patient recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants received Cellgram-DC-PC in a single-group, open-label study.
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04615845
Sponsor's protocol ID
PMC-DC-01
Status last verified
Sep 2026
First submitted
22 Oct 2020
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be made available to other researchers.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cellgram-DC-PC in people with Metastatic Castration Resistant Prostate Cancer, run by Pharmicell Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Difficulties in patient recruitment.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event (time frame: From informed consent to the end of treatment at Week 28.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04615845.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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