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

Sponsor
Pharmicell Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04614051
Collaborator
(none)
10
1
1
13
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Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Cellgram-DC
Phase 1

Detailed Description

To evaluate the safety of an autologous dendritic cell(DC) anticancer immune cell therapy (Cellgram-DC) for the treatment of advanced or recurrent epithelial ovarian cancer.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cellgram-DC

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

Biological: Cellgram-DC
Patients will receive 3 times every 2 weeks injection of Cellgram-DC(Autologous dendritic cell) subcutaneous injection near the upper arm lymph nodes
Other Names:
  • Autologous dendritic cell anticancer immune cell therapy for the treatment of ovarian cancer in patients with advanced or recurrent epithelial ovarian cancer
  • Outcome Measures

    Primary Outcome Measures

    1. The Measure CTCAE of Safety [-5, -3, 0, 2, 4, 8, 16 and 28 weeks]

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

    Secondary Outcome Measures

    1. Immune response evaluation (INF-r) [0, 2, 8, 16 and 28 weeks]

      The tumor antigen-specific immune response induced after administration compared to before Investigational Product(IP) administration was confirmed by measuring changes in the secretion of cytokines (INF-r) in serum (ELISA).

    2. Immune response evaluation (IL-12) [0, 2, 8, 16 and 28 weeks]

      The tumor antigen-specific immune response induced after administration compared to before Investigational Product(IP) administration was confirmed by measuring changes in the secretion of cytokines (IL-12) in serum (ELISA).

    3. Measurement of changes in tumor marker test results (CA-125) [0, 2, 4, 8, 16 and 28 weeks]

      Changes in tumor marker test results (CA-125) are measured at each time point (V4, V5, V6, V7, V8) after administration compared to before (V3) Investigational Product(IP) administration.

    4. Evaluation of solid tumor reflection at the time of follow-up observation [8 and 28 weeks]

      Responses of target/non-target lesions evaluated by the solid tumor reflection evaluation criteria (RECIST 1.1) at the time of follow-up (V6, V8)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. 20 and under 81 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan medical center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Pharmicell Co., Ltd.

    Investigators

    • Principal Investigator: Yongman Kim, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pharmicell Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04614051
    Other Study ID Numbers:
    • PMC-DC-02
    First Posted:
    Nov 3, 2020
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021