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

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.

Inclusion criteria

• 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
• 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)

Exclusion criteria

• 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
• 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