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Ovarian CancerPhase 1NCT04614051

A Phase 1 Study of Cellgram-DC in Patients With Advanced or Recurrent Epithelial Ovarian Cancer

A Phase 1 study testing Cellgram-DC in people with Ovarian Cancer and Advanced Epithelial Ovarian 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, an autologous dendritic cell-based cancer immunotherapy, in patients with advanced or recurrent epithelial ovarian cancer. Read more about this study

Who is it for?
Ages 19 to 79 years, women only
What is being tested?
Cellgram-DC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteSouth Korea
Study dates
9 Feb 2022to 19 Jul 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 19 and under 80 years
  • Patients with Fédération Internationale de Gynécologie et d' Obstétrique(FIGO) stage III with histologically confirmed advanced or recurrent epithelial ovarian cancer (Serous, endometrioid, and mucinous only), fallopian tube cancer, and primary peritoneal cancer (residual tumor size <1cm)
  • Patients who have undergone tumor reduction or staging and complete or plan to complete platinum-based chemotherapy
  • In case of complete or partial response in primary or secondary chemotherapy
  • Whole body performance status: European Cooperative Oncology Group(ECOG) 0~1
  • Patients whose BRCA gene mutation test results can be confirmed
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  • Patients whose life expectancy is at least 6 months or longer
  • Hb ≥ 8.0 g/dL, Absolute Neutrophil Count(ANC) ≥ 1,500/mm3, Platelets ≥ 100,000/mm3
  • Serum Creatinine ≤ 1.5 x Upper Limit of Normal(ULN) or Serum Creatinine> 1.5 x ULN and Calculated Creatinine Clearance> 30 mL/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 a medically recognized contraceptive method (diaphragm method used with spermicide, abstinence) during participation in the clinical trial (injection or implantable hormone therapy is not appropriate).
  • Patients who voluntarily participated in clinical trials and signed the Informed Contents Form (ICF)

Who cannot join

  • Patients with malignant tumors other than non-melanoma skin cancer in the past 3 years
  • Patients with brain metastases
  • 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 who use or plan to use Poly (ADP-ribose) polymerase (PARP) inhibitors due to the confirmed Breast Cancer Susceptibility Gene(BRCA) 1 or BRCA 2 mutation
  • 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
  • Patients expected to need systemic chemotherapy, biotherapy, or immunotherapy for therapeutic purposes
  • 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
  • Pregnant or breastfeeding patients
  • 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 Advanced or Recurrent Epithelial Ovarian Cancer

The goal of this clinical trial was to evaluate the safety of Cellgram-DC, an autologous dendritic cell-based cancer immunotherapy, in patients with advanced or recurrent epithelial ovarian cancer.

Read the detailed description

Cellgram-DC is an autologous dendritic cell-based cancer immunotherapy developed for patients with advanced or recurrent epithelial ovarian cancer. This was a Phase 1, single-center, open-label clinical trial designed to characterize the safety profile of Cellgram-DC following administration.

Being tested
Cellgram-DC
Keywords
Cellgram-DC, Epithelial Ovarian Cancer, Ovarian Cancer, Recurrent Ovarian Cancer, Dendritic Cell, Cancer Immunotherapy
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

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

  • Cellgram-DCBiological

    Also called Autologous dendritic cell anticancer immune cell therapy for the treatment of ovarian cancer in patients with advanced or recurrent epithelial ovarian cancer

    Cellgram-DC is an autologous dendritic cell therapy administered by subcutaneous injection near the right or left axillary lymph nodes every 2 weeks for a total of 3 doses.

Study groups in NCT04614051
Study groupRoleWhat they receive
Cellgram-DCExperimentalParticipants received Cellgram-DC by subcutaneous injection near the right or left axillary lymph nodes every 2 weeks for a total of 3 doses.
Receives: Biological: Cellgram-DC

What is being measured

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

  1. Adverse Events

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

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

Secondary outcomes (3)

  1. Immune Response

    Tumor antigen-specific immune responses were evaluated by measuring changes in serum IFN-γ and IL-12 levels using ELISA.

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

  2. Change in CA-125

    Changes in serum CA-125 levels were evaluated compared with pre-treatment (Week 0).

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

  3. Tumor Response by RECIST 1.1

    Tumor response of target and non-target lesions was evaluated according to RECIST version 1.1.

    Measured: At Week 8 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 posted3 Nov 2020
  2. Study start9 Feb 2022
  3. Primary completion8 Jun 2022
  4. Study completion19 Jul 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.
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04614051
Sponsor's protocol ID
PMC-DC-02
Status last verified
Sep 2026
First submitted
22 Oct 2020
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cellgram-DC in people with Ovarian Cancer and Advanced Epithelial Ovarian 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 13 inclusion and 17 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 18 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 Events (time frame: From enrollment 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 NCT04614051.

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 18 Sep 2026.

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