Therapeutic Vaccine Plus PD-1 Knockout in Prostate Cancer Treatment
NCT ID: NCT03525652
Last Updated: 2018-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2018-02-22
2021-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Therapeutic vaccine
Therapeutic vaccine will be prepared ex vivo using the peripheral mononuclear cells from the patients and the vaccine (as maturated dendritic cells) will be infused back to the patients in 3 times with a 2-week interval.
Therapeutic vaccine
The therapeutic vaccine will be custom prepared ex vivo using the peripheral mononuclear cells from the patient and the vaccine which presented as maturated dendritic cells will be infused back to the patients in 3 times.
Therapeutic vaccine plus PD-1 knockout
Therapeutic vaccine and PD-1 knockout T cells will be prepared ex vivo using the white cells from the patients and the vaccine (as maturated dendritic cells) and maturated PD-1 knockout T cells will be infused back to the patients in 3 times.
Therapeutic vaccine
The therapeutic vaccine will be custom prepared ex vivo using the peripheral mononuclear cells from the patient and the vaccine which presented as maturated dendritic cells will be infused back to the patients in 3 times.
PD-1 Knockout T Cells
PD-1 knockout T cells will be custom prepared ex vivo using the white blood cells from the patient and the maturated PD-1 knockout T cells will be infused back to the patients in 3 times.
PD-1 knockout T cells
PD-1 knockout T cells will be prepared ex vivo using the white cells from the patients and the maturated PD-1 knockout T cells will be infused back to the patients in 3 times.
PD-1 Knockout T Cells
PD-1 knockout T cells will be custom prepared ex vivo using the white blood cells from the patient and the maturated PD-1 knockout T cells will be infused back to the patients in 3 times.
Interventions
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Therapeutic vaccine
The therapeutic vaccine will be custom prepared ex vivo using the peripheral mononuclear cells from the patient and the vaccine which presented as maturated dendritic cells will be infused back to the patients in 3 times.
PD-1 Knockout T Cells
PD-1 knockout T cells will be custom prepared ex vivo using the white blood cells from the patient and the maturated PD-1 knockout T cells will be infused back to the patients in 3 times.
Eligibility Criteria
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Inclusion Criteria
* Evidence of metastasis in the soft tissue and/or bone.
* Progressive androgen independent castrate resistant prostate cancer.
* Serum PSA ≥ 5.0 ng/mL
* Estimated life expectancy ≥ 6 months.
* Castrate level of testosterone (\< 50 ng/dL) achieved via medical or surgical castration.
* Adequate hematologic, renal and liver function.
Exclusion Criteria
* Presence of moderate to severe pain treating with opioid analgesics within 21 days prior to registration.
* ECOG score ≥ 2.
* Any other systemic therapy for prostate cancer (except for medical castration).
* Participation in previous study using Provenge (Sipuleucel-T) or similar product.
* Known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography \> 50%) or spinal cord compression.
* Known malignancies other than prostate cancer requiring active treatment within 6 months.
* A requirement for systemic immunosuppressive therapy for any reason.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to this product or granulocyte-macrophage colony-stimulating factor.
* Any infection requiring parenteral antibiotic therapy or causing fever (temp \> 100.5°F or \> 38.1°C) within 1 week prior to registration.
* Any medical intervention or other condition which, in the opinion of the Principal Investigator could compromise adherence with study requirements or otherwise compromise the study's objectives.
* Treatment with any of the following medications or interventions within 28 days of registration:
Systemic use of corticosteroids, External beam radiation therapy or surgery, Use of non-steroidal antiandrogens Dietary and herbal supplements, as well as alternative treatments that have evidence of hormonal and/or anticancer properties (e.g., prostate cancer (PC) -SPES or PC-SPEC) and saw palmetto, Megestrol acetate (Megace®), diethylstilbesterol (DES), or cyproterone acetate, ++Ketoconazole, 5-alpha-reductase inhibitors, Treatment with any other investigational product Treatment with chemotherapy High dose calcitriol \[1,25(OH)2Vitamin D\] (i.e., \> 0.5 mcg/day). Initiation or discontinuation of bisphosphonate therapy
18 Years
70 Years
MALE
No
Sponsors
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Guangzhou Anjie Biomedical Technology Co., Ltd.
INDUSTRY
University of Technology, Sydney
OTHER
The First Affiliated Hospital of Guangdong Pharmaceutical University
OTHER
Responsible Party
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Size Chen
Professor
Principal Investigators
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Size Chen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Guangdong Pharmaceutical University
Locations
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First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Professor Size Chen
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2018-007
Identifier Type: -
Identifier Source: org_study_id
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