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

NCT ID: NCT04614051

Last Updated: 2023-01-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-30
• Study Completion Date: 2022-05-10

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

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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cellgram-DC

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

Group Type: EXPERIMENTAL

Cellgram-DC

Intervention Type: BIOLOGICAL

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

Interventions

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

Intervention Type: BIOLOGICAL

Other Intervention Names

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

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pharmicell Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongman Kim

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan medical center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

PMC-DC-02

Identifier Type: -

Identifier Source: org_study_id