Training a Patient's own immune cells to fight advanced prostate cancer
NCT ID NCT04615845
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.
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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
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3 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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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
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19 to 79 years
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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
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Asan medical center
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Radioactive missile aims at prostate cancer that spread
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
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- Can a Cancer-Targeting drug slow advanced prostate cancer?
- Can a smart radiation drug hunt down prostate cancer cells?