Training a Patient's own immune cells to fight advanced prostate cancer

NCT ID NCT04615845

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing a cancer immunotherapy called Cellgram-DC-PC in men with metastatic castration-resistant prostate cancer, an advanced form of the disease that has spread and no longer responds to hormone therapy. The treatment uses dendritic cells, which are immune cells made from each patient's own blood, to help the body recognize and attack prostate cancer cells. Participants receive three injections of these cells near the lymph nodes in the groin over about a month. The trial's main goal is to check whether the treatment is safe and causes side effects, while also looking at immune responses and changes in prostate-specific antigen (PSA) levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Autologous dendritic cell immunotherapy (Cellgram-DC-PC), made from a patient's own immune cells
What this could lead to
If it works, this approach could offer a way to train the immune system to attack prostate cancer that has spread and stopped responding to hormone therapy.
What could go wrong
This is a very early Phase 1 trial with only a few participants, so its main goal is checking safety, not proving the treatment works. The immune response it aims to create may not be strong enough to shrink tumors or slow the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

3 people

The number who actually took part.

Started

Jul 2021

Finished

Jun 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 79 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 19 and under 80 years 2. Histologically confirmed prostate adenocarcinoma 3. Patients with stage M1a or M1b with extrapelvic lymph nodes and bone metastases 4. 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: 1. 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 2. Radiological progression: appearance of new lesions; 2 or more new lesions on the bone scan 5. Asymptomatic or mild patients after previous treatment 1. Patients who have not used narcotic analgesics within 21 days prior to enrollment 2. Patients with an average weekly pain of less than 4 on the Visual Analogue Scale(VAS) (out of 10) 6. Combination of Luteinizing hormone-releasing hormone(LHRH) analogs (leuprolide (Lupron, Viadur, Eligard) and goserelin (Zoladex, etc.) for the inhibition of gonadotropin is allowed 7. Whole body performance status: European Cooperative Oncology Group(ECOG) 0\~1 8. Patients whose life expectancy is at least 6 months or longer 9. Hb ≥ 8.0g/dL, Absolute Neutrophil Count(ANC) ≥ 1,500/mm3, Platelets ≥ 100,000/mm3 10. Serum Creatinine ≤ 2.0 x Upper Limit of Normal(ULN) or Calculated Creatinine Clearance \> 30mL/min 11. Total Bilirubin ≤ 1.5 x ULN or Direct bilirubin ≤ ULN, Aminotransferase (AST)/Alanine aminotransferase(ALT) \<2.5 x ULN 12. Patients who did not receive surgery, radiation therapy, or immunotherapy within the last 6 weeks and recovered from side effects 13. Patients who agreed to use medically recognized contraceptive methods during the clinical trial participation period 14. Patients who voluntarily participated in clinical trials and signed the Informed Contents Form (ICF) Exclusion Criteria: 1. Patients who have a local recurrence and are scheduled for local treatment. 2. Patients with malignant tumors other than non-melanoma skin cancer in the past 3 years 3. Patients with visceral metastases (metastases to the lungs, liver, adrenal glands, peritoneum, brain, etc.) 4. Patients who previously received anti-tumor immunotherapy (anti-PD1, anti-PDL1 or anti-PDL2, etc.) or participated in immunotherapy-related clinical trials 5. Patients with active autoimmune diseases requiring systemic immunosuppression treatment (e.g., immunosuppressants such as cyclosporin A or azathioprine or steroids for disease control) 6. Patients with medical conditions requiring continuous or intermittent administration of systemic steroids or immunosuppressants 7. 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) 8. Patients with a history of organ or hematopoietic stem cell transplantation 9. Patients with acute or chronic infections requiring systemic treatment 10. Patients known to be infected with human immunodeficiency virus (HIV)/serum positive 11. Patients with active hepatitis A, B or C 12. Patients with untreated syphilis (Fluorescent Treponemal Antibody Absorption Test (FTA-ABS) Immunoglobulin M positive patients) 13. Patients expected to require therapeutic biotherapy or immunotherapy 14. 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 15. Patients with a history of anaphylaxis to gentamicin 16. Others, if the person in charge of the study determines that it is not suitable for the clinical trial

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Asan medical center

    Seoul, South Korea

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