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

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

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

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer
• Intervention / Treatment: Biological: Cellgram-DC

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune response evaluation (INF-r)	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).	0, 2, 8, 16 and 28 weeks
Immune response evaluation (IL-12)	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).	0, 2, 8, 16 and 28 weeks
Measurement of changes in tumor marker test results (CA-125)	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.	0, 2, 4, 8, 16 and 28 weeks
Evaluation of solid tumor reflection at the time of follow-up observation	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)	8 and 28 weeks

Collaborators and Investigators

• Sponsor: Pharmicell Co., Ltd.
• Investigators: Principal Investigator: Yongman Kim, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Estimate): January 2, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: PMC-DC-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No