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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04614051
• Other study ID #: PMC-DC-02
• Status: Terminated
• Phase: Phase 1
• Start date: March 30, 2021
• Est. completion date: May 10, 2022

Study information

• Verified date: December 2022
• Source: Pharmicell Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 10, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pharmicell Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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