Safety Evaluation of Autologous Dendritic Cell Anticancer Immune Cell Therapy (Cellgram-DC)

NCT04614051 | Terminated Phase 1

• 1 other identifier: PMC-DC-02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase 1 study to evaluate the safety of cancer immunotherapy with autologous dendritic cells in patients with advanced or recurrent epithelial ovarian cancer

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• The Measure CTCAE of Safety

  The level of Adverse Event (AE) is described in accordance with the Common Terminology Criteria for Adverse Event (CTCAE) (Version 5.0).

  -5, -3, 0, 2, 4, 8, 16 and 28 weeks

Secondary Outcomes (4)

• Immune response evaluation (INF-r)

  0, 2, 8, 16 and 28 weeks

• Immune response evaluation (IL-12)

  0, 2, 8, 16 and 28 weeks

• Measurement of changes in tumor marker test results (CA-125)

  0, 2, 4, 8, 16 and 28 weeks

• Evaluation of solid tumor reflection at the time of follow-up observation

  8 and 28 weeks

Study Arms (1)

Cellgram-DC

EXPERIMENTAL

Cellgram-DC is injected Subcutaneous injection near the upper arm lymph nodes

Biological: Cellgram-DC

Interventions

Cellgram-DC BIOLOGICAL

Patients will receive 3 times every 2 weeks injection of Cellgram-DC(Autologous dendritic cell) subcutaneous injection near the upper arm lymph nodes

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

Cellgram-DC

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (1)

Asan medical center

Seoul, South Korea

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Yongman Kim

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 3, 2020
• Study Start: March 30, 2021
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

KR (1)