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

Study Overview
=================
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)

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.

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)

Conditions
-----------------
Castration Resistant Prostate Cancer, CRPC

Intervention / Treatment
-----------------
* Biological: Cellgram-DC-PC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 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 Patients who did not receive surgery, radiation therapy, or immunotherapy within the last 6 weeks and recovered from side effects Patients who agreed to use medically recognized contraceptive methods during the clinical trial participation period Patients who voluntarily participated in clinical trials and signed the Informed Contents Form (ICF) Exclusion Criteria: 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 Others, if the person in charge of the study determines that it is not suitable for the clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cellgram-DC-PC<br>Cellgram-DC-PC is injected subcutaneously near the inguinal lymph nodes | Biological: Cellgram-DC-PC<br>* Patients will receive 3 times every 2 weeks injection of Cellgram-DC-PC(Autologous dendritic cell) subcutaneously near the inguinal lymph nodes<br>* Other names: Autologous dendritic cell anti-cancer immune cell therapy for prostate cancer treatment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Measurement of changes in tumor marker test results (PSA) | 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 |