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

December 29, 2022 updated by: Pharmicell Co., Ltd.

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)

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. 19 and under 80 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) and If either a or b is satisfied:

    1. 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
    2. Radiological progression: appearance of new lesions; 2 or more new lesions on the bone scan

  5. Asymptomatic or mild patients after previous treatment

    1. Patients who have not used narcotic analgesics within 21 days prior to enrollment
    2. Patients with an average weekly pain of less than 4 on the Visual Analogue Scale(VAS) (out of 10)
  6. Combination of Luteinizing hormone-releasing hormone(LHRH) analogs (leuprolide (Lupron, Viadur, Eligard) and goserelin (Zoladex, etc.) for the inhibition of gonadotropin is allowed
  7. Whole body performance status: European Cooperative Oncology Group(ECOG) 0~1
  8. Patients whose life expectancy is at least 6 months or longer
  9. Hb ≥ 8.0g/dL, Absolute Neutrophil Count(ANC) ≥ 1,500/mm3, Platelets ≥ 100,000/mm3
  10. Serum Creatinine ≤ 2.0 x Upper Limit of Normal(ULN) or Calculated Creatinine Clearance > 30mL/min
  11. Total Bilirubin ≤ 1.5 x ULN or Direct bilirubin ≤ ULN, Aminotransferase (AST)/Alanine aminotransferase(ALT) <2.5 x ULN
  12. Patients who did not receive surgery, radiation therapy, or immunotherapy within the last 6 weeks and recovered from side effects
  13. Patients who agreed to use medically recognized contraceptive methods during the clinical trial participation period
  14. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Measure CTCAE of Safety
Time Frame: 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).
For 28 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immune response evaluation (INF-r)
Time Frame: 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).
0, 2, 8, 16 and 28 weeks
Immune response evaluation (IL-12)
Time Frame: 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).
0, 2, 8, 16 and 28 weeks
Measurement of changes in tumor marker test results (PSA)
Time Frame: 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.
0, 2, 4, 8, 16 and 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharmicell Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: BUMJIN LIM, Ph.D, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PMC-DC-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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