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

Sponsor
Pharmicell Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04615845
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
16.9
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase 1 study to evaluate the safety of cancer immunotherapy with autologous dendritic cells(DC) in patients with metastatic castration resistant prostate cancer (mCRPC)

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

Detailed Description

To evaluate the safety of an autologous dendritic cell anticancer immune cell therapy (Cellgram-DC-PC) for the treatment of prostate cancer in patients with metastatic castration-resistant prostate 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 Metastatic Castration Resistant Prostate Cancer (mCRPC)
Actual Study Start Date :
Jul 5, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cellgram-DC-PC

Cellgram-DC-PC is injected subcutaneously near the inguinal lymph nodes

Biological: Cellgram-DC-PC
Patients will receive 3 times every 2 weeks injection of Cellgram-DC-PC(Autologous dendritic cell) subcutaneously near the inguinal lymph nodes
Other Names:
  • Autologous dendritic cell anti-cancer immune cell therapy for prostate cancer treatment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The Measure CTCAE of Safety [For 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 (PSA) [0, 2, 4, 8, 16 and 28 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 20 and under 81 years

    2. Histologically confirmed prostate adenocarcinoma

    3. Patients with stage M1a or M1b with extrapelvic lymph nodes and bone metastases

    4. Patients diagnosed with castration-resistant prostate cancer after failure of male hormone deprivation therapy (Castrate levels of testosterone <50 ng/dL)

    5. Biochemical progression: Prostate Specific Antigen (PSA) increases three times in a row at 1 week intervals, two 50% increases compared to the lowest point, PSA> 2ng/mL, or

    6. Radiological progression: appearance of new lesions; 2 or more new lesions on the bone scan

    7. Asymptomatic or mild patients after previous treatment

    8. Patients who have not used narcotic analgesics within 21 days prior to enrollment

    9. Patients with an average weekly pain of less than 4 on the Visual Analogue Scale(VAS) (out of 10)

    10. Combination of Luteinizing hormone-releasing hormone(LHRH) analogs (leuprolide (Lupron, Viadur, Eligard) and goserelin (Zoladex, etc.) for the inhibition of gonadotropin is allowed

    11. Whole body performance status: European Cooperative Oncology Group(ECOG) 0~1

    12. Patients whose life expectancy is at least 6 months or longer

    13. Hb ≥ 8.0g/dL, Absolute Neutrophil Count(ANC) ≥ 1,500/mm3, Platelets ≥ 100,000/mm3

    14. Serum Creatinine ≤ 1.5 x Upper Limit of Normal(ULN) or Serum Creatinine> 1.5 x ULN and Calculated Creatinine Clearance> 30mL/min

    15. Total Bilirubin ≤ 1.5 x ULN or Direct bilirubin ≤ ULN, Aminotransferase (AST)/Alanine aminotransferase(ALT) <2.5 x ULN

    16. Patients who did not receive surgery, radiation therapy, or immunotherapy within the last 6 weeks and recovered from side effects

    17. Patients who agreed to use medically recognized contraceptive methods during the clinical trial participation period

    18. Patients who voluntarily participated in clinical trials and signed the Informed Contents Form (ICF)

    Exclusion Criteria:

    1. Patients who have a local recurrence and are scheduled for local treatment.

    2. Patients with malignant tumors other than non-melanoma skin cancer in the past 3 years

    3. Patients with visceral metastases (metastases to the lungs, liver, adrenal glands, peritoneum, brain, etc.)

    4. Patients who previously received anti-tumor immunotherapy (anti-PD1, anti-PDL1 or anti-PDL2, etc.) or participated in immunotherapy-related clinical trials

    5. Patients with active autoimmune diseases requiring systemic immunosuppression treatment (e.g., immunosuppressants such as cyclosporin A or azathioprine or steroids for disease control)

    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 (Fluorescent Treponemal Antibody Absorption Test (FTA-ABS) Immunoglobulin M positive patients)

    13. Patients expected to require therapeutic biotherapy or immunotherapy

    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. 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: Chungsu Kim, Ph.D, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pharmicell Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04615845
    Other Study ID Numbers:
    • PMC-DC-01
    First Posted:
    Nov 4, 2020
    Last Update Posted:
    Oct 22, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Oct 22, 2021