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Safety Evaluation of Autologous Dendritic Cell Anticancer Immune Cell Therapy (Cellgram-DC-PC) | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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)

NCT04615845•Pharmicell Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - 79 years

Sex

MALE

Healthy Volunteers

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
+8 more criteria

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
+6 more criteria

Locations (1)

Asan medical center

Seoul, South Korea

Key Dates

Start Date

June 21, 2021

Primary Completion Date

February 15, 2022

Completion Date

February 15, 2022

Last Updated

January 3, 2023

Enrollment

ACTUAL participants

Conditions

Castration Resistant Prostate Cancer, CRPC

Interventions

Cellgram-DC-PC

BIOLOGICAL