Back to resultsTherapeutic Vaccine Plus PD-1 Knockout in Prostate Cancer Treatment
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Therapeutic vaccine
PD-1 Knockout T Cells
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Therapeutic vaccine, PD-1 knockout
Eligibility Criteria
Inclusion Criteria:
• Histologically confirmed prostate cancer (stage IV, according to NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer, Version 2.2017)
- 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 known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites.
- 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
Sites / Locations
- First Affiliated Hospital of Guangdong Pharmaceutical UniversityRecruiting
- Professor Size ChenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
Therapeutic vaccine
Therapeutic vaccine plus PD-1 knockout
PD-1 knockout T cells
Arm Description
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 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.
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.
Outcomes
Primary Outcome Measures
Number of participants with adverse events and dose limiting toxicities as assessed by CTCAE v4.0
Safety and tolerability of dose of therapeutic vaccine in combination with PD-1 Knockout T cells will be assessed using CTCAE v4.0
Secondary Outcome Measures
Response Rate
Will be assessed according to the revised RECIST guideline v1.1
Progression free survival - PFS
Time from treatment to date of first documented progression or date of death
Overall Survival - OS
Measure the time from the commencement of treatment to death
Peripheral blood circulating tumor DNA
Circuiting tumor DNA will be measured at baseline and 6 weeks after treatment
Full Information
NCT ID
NCT03525652
First Posted
April 26, 2018
Last Updated
May 3, 2018
Sponsor
The First Affiliated Hospital of Guangdong Pharmaceutical University
Collaborators
Guangzhou Anjie Biomedical Technology Co., Ltd., University of Technology, Sydney
1. Study Identification
Unique Protocol Identification Number
NCT03525652
Brief Title
Therapeutic Vaccine Plus PD-1 Knockout in Prostate Cancer Treatment
Official Title
Clinical Assessment of a Therapeutic Vaccine in Combination With PD-1 Knockout T Cells in the Treatment of Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 22, 2018 (Actual)
Primary Completion Date
February 22, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangdong Pharmaceutical University
Collaborators
Guangzhou Anjie Biomedical Technology Co., Ltd., University of Technology, Sydney
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to evaluate the safety and efficacy of a therapeutic vaccine in combination with PD-1 knockout T cells in the treatment of advanced prostate cancer.
Detailed Description
This is a phase 1/2 clinical study investigating the safety and efficacy of a therapeutic vaccine in combination with PD-1 knockout T cells in the treatment of advanced prostate cancer. The therapeutic vaccine is a customized product involving ex vivo treatment of the patient's peripheral blood mononuclear cells with a recombinant fusion protein (PAP-GM-CSF) to activate the expression of the antigen that would activate the immune function to kill cancer cells. The PD-1 knockout engineered T cells are also prepared using patient's T cells in which PD-1 gene will be knocked out using CRISPR Cas9 technology. The therapeutic vaccine and PD-1 knockout T cells will be infused back to the patient in 3 times with a 2-week interval.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Therapeutic vaccine, PD-1 knockout
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic vaccine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Therapeutic vaccine plus PD-1 knockout
Arm Type
Experimental
Arm Description
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.
Arm Title
PD-1 knockout T cells
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Therapeutic vaccine
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
PD-1 Knockout T Cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with adverse events and dose limiting toxicities as assessed by CTCAE v4.0
Description
Safety and tolerability of dose of therapeutic vaccine in combination with PD-1 Knockout T cells will be assessed using CTCAE v4.0
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Response Rate
Description
Will be assessed according to the revised RECIST guideline v1.1
Time Frame
6 months
Title
Progression free survival - PFS
Description
Time from treatment to date of first documented progression or date of death
Time Frame
Up to 12 months
Title
Overall Survival - OS
Description
Measure the time from the commencement of treatment to death
Time Frame
Death
Title
Peripheral blood circulating tumor DNA
Description
Circuiting tumor DNA will be measured at baseline and 6 weeks after treatment
Time Frame
8 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate cancer is only presented in male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Histologically confirmed prostate cancer (stage IV, according to NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer, Version 2.2017)
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 known lung, liver, or brain metastases, malignant pleural effusions, or malignant ascites.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Size Chen, MD, PhD
Phone
+8613710956393
Email
13710956393@139.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhizhou Huang, MSc
Phone
+8613268258980
Email
hzhizhou@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Size Chen, MD, PhD
Organizational Affiliation
The First Affiliated Hospital of Guangdong Pharmaceutical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Guangdong Pharmaceutical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guobiao Huang
Phone
86-20-39352064
Email
153706227@qq.com
Facility Name
Professor Size Chen
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Size Chen, MD,PhD
Phone
+8613720956393
Email
13720956393@139.com
First Name & Middle Initial & Last Name & Degree
Zhizhou Huang, MSc
Phone
+8613268258980
Email
hzhizhou@sina.com
First Name & Middle Initial & Last Name & Degree
Yiguang Lin, MD, PhD
First Name & Middle Initial & Last Name & Degree
Size Chen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Micheal Yin, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Therapeutic Vaccine Plus PD-1 Knockout in Prostate Cancer Treatment
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