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

NCT04615845 | Terminated Phase 1

• 1 other identifier: PMC-DC-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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)

Conditions

Castration Resistant Prostate Cancer, CRPC

Outcome Measures

Primary Outcomes (1)

• 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).

  For 28 weeks

Secondary Outcomes (3)

• Immune response evaluation (INF-r)

  0, 2, 8, 16 and 28 weeks

• Immune response evaluation (IL-12)

  0, 2, 8, 16 and 28 weeks

• Measurement of changes in tumor marker test results (PSA)

  0, 2, 4, 8, 16 and 28 weeks

Study Arms (1)

Cellgram-DC-PC

EXPERIMENTAL

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

Biological: Cellgram-DC-PC

Interventions

Cellgram-DC-PC BIOLOGICAL

Patients will receive 3 times every 2 weeks injection of Cellgram-DC-PC(Autologous dendritic cell) subcutaneously near the inguinal lymph nodes

Also known as: Autologous dendritic cell anti-cancer immune cell therapy for prostate cancer treatment

Cellgram-DC-PC

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and under 80 years
• Histologically confirmed prostate adenocarcinoma
• Patients with stage M1a or M1b with extrapelvic lymph nodes and bone metastases
• Patients diagnosed with castration-resistant prostate cancer after failure of male hormone deprivation therapy (Castrate levels of testosterone \<50 ng/dL) and If either a or b is satisfied:
• 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
• Radiological progression: appearance of new lesions; 2 or more new lesions on the bone scan
• Asymptomatic or mild patients after previous treatment
• Patients who have not used narcotic analgesics within 21 days prior to enrollment
• Patients with an average weekly pain of less than 4 on the Visual Analogue Scale(VAS) (out of 10)
• Combination of Luteinizing hormone-releasing hormone(LHRH) analogs (leuprolide (Lupron, Viadur, Eligard) and goserelin (Zoladex, etc.) for the inhibition of gonadotropin is allowed
• Whole body performance status: European Cooperative Oncology Group(ECOG) 0\~1
• Patients whose life expectancy is at least 6 months or longer
• Hb ≥ 8.0g/dL, Absolute Neutrophil Count(ANC) ≥ 1,500/mm3, Platelets ≥ 100,000/mm3
• Serum Creatinine ≤ 2.0 x Upper Limit of Normal(ULN) or Calculated Creatinine Clearance \> 30mL/min
• Total Bilirubin ≤ 1.5 x ULN or Direct bilirubin ≤ ULN, Aminotransferase (AST)/Alanine aminotransferase(ALT) \<2.5 x ULN

You may not qualify if:

• Patients who have a local recurrence and are scheduled for local treatment.
• Patients with malignant tumors other than non-melanoma skin cancer in the past 3 years
• Patients with visceral metastases (metastases to the lungs, liver, adrenal glands, peritoneum, brain, etc.)
• Patients who previously received anti-tumor immunotherapy (anti-PD1, anti-PDL1 or anti-PDL2, etc.) or participated in immunotherapy-related clinical trials
• Patients with active autoimmune diseases requiring systemic immunosuppression treatment (e.g., immunosuppressants such as cyclosporin A or azathioprine or steroids for disease control)
• Patients with medical conditions requiring continuous or intermittent administration of systemic steroids or immunosuppressants
• 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)
• Patients with a history of organ or hematopoietic stem cell transplantation
• Patients with acute or chronic infections requiring systemic treatment
• Patients known to be infected with human immunodeficiency virus (HIV)/serum positive
• Patients with active hepatitis A, B or C
• Patients with untreated syphilis (Fluorescent Treponemal Antibody Absorption Test (FTA-ABS) Immunoglobulin M positive patients)
• Patients expected to require therapeutic biotherapy or immunotherapy
• 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
• Patients with a history of anaphylaxis to gentamicin

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (1)

Asan medical center

Seoul, South Korea

Location

Study Officials

• BUMJIN LIM, Ph.D

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 4, 2020
• Study Start: June 21, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

KR (1)