Advanced Epithelial Ovarian Cancer, Ovarian Cancer, Recurrent Epithelial Cancer of Ovary
Conditions
Keywords
Cellgram-DC, Epithelial Ovarian Cancer, Ovarian Cancer, Recurrent Ovarian Cancer, Dendritic Cell, Cancer Immunotherapy
Brief 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.
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.
Interventions
BIOLOGICALCellgram-DC
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.
Sponsors
Pharmicell Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This was an open-label study in which both investigators and participants were aware of the assigned intervention.
Intervention model description
All participants received Cellgram-DC.
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | From enrollment to the end of treatment at Week 28. | Adverse events (AEs) were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune Response | At baseline, Week 4, Week 8, Week 16, and Week 28. | Tumor antigen-specific immune responses were evaluated by measuring changes in serum IFN-γ and IL-12 levels using ELISA. |
| Change in CA-125 | At baseline, Week 2, Week 4, Week 8, Week 16, and Week 28. | Changes in serum CA-125 levels were evaluated compared with pre-treatment (Week 0). |
| Tumor Response by RECIST 1.1 | At Week 8 and Week 28. | Tumor response of target and non-target lesions was evaluated according to RECIST version 1.1. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORYongman Kim
Asan Medical Center
Outcome results
None listed