Clinical trial · Interventional
A Phase 1 Study of Cellgram-DC in Patients With Advanced or Recurrent Epithelial Ovarian Cancer
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
NCT04614051CI-TRIAL-00062974terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Why stopped (as posted): Difficulties in patient recruitment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Epithelial Ovarian Cancer | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Recurrent Epithelial Cancer of Ovary | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cellgram-DC | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cellgram-DC
- description
- Participants received Cellgram-DC by subcutaneous injection near the right or left axillary lymph nodes every 2 weeks for a total of 3 doses.
- interventionNames
- Biological: Cellgram-DC
Primary outcomes (1)
- measure
- Adverse Events
- timeFrame
- From enrollment to the end of treatment at Week 28.
- description
- Adverse events (AEs) were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Secondary outcomes (3)
- measure
- Immune Response
- timeFrame
- At baseline, Week 4, Week 8, Week 16, and Week 28.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. 19 and under 80 years 2. 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) 3. Patients who have undergone tumor reduction or staging and complete or plan to complete platinum-based chemotherapy 4. In case of complete or partial response in primary or secondary chemotherapy 5. Whole body performance status: European Cooperative Oncology Group(ECOG) 0\~1 6. Patients whose BRCA gene mutation test results can be confirmed 7. Patients whose life expectancy is at least 6 months or longer 8. Hb ≥ 8.0 g/dL, Absolute Neutrophil Count(ANC) ≥ 1,500/mm3, Platelets ≥ 100,000/mm3 9. Serum Creatinine ≤ 1.5 x Upper Limit of Normal(ULN) or Serum Creatinine\> 1.5 x ULN and Calculated Creatinine Clearance\> 30 mL/min 10. Total Bilirubin ≤ 1.5 x ULN or Direct bilirubin ≤ ULN, Aminotransferase (AST)/Alanine aminotransferase(ALT) \<2.5 x ULN 11. Patients who did not receive surgery, radiation therapy, or immunotherapy within the last 6 weeks and recovered from side effects 12. 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). 13. Patients who voluntarily participated in clinical trials and signed the Informed Contents Form (ICF) Exclusion Criteria: 1. Patients with malignant tumors other than non-melanoma skin cancer in the past 3 years 2. Patients with brain metastases 3. Patients who previously received anti-tumor immunotherapy (anti-PD1, anti-PDL1 or anti-PDL2, etc.) or participated in immunotherapy-related clinical trials 4. Patients with active autoimmune diseases requiring systemic immunosuppression treatment (e.g., immunosuppressants such as cyclosporin A or azathioprine, or steroids for disease control) 5. 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 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 13. Patients expected to need systemic chemotherapy, biotherapy, or immunotherapy for therapeutic purposes 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. Pregnant or breastfeeding patients 17. Others, if the person in charge of the study determines that it is not suitable for the clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.