NCT03525652

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for phase_1 prostate-cancer

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

3 years

First QC Date

April 26, 2018

Last Update Submit

May 3, 2018

Conditions

Prostate Cancer

Keywords

Prostate CancerTherapeutic vaccinePD-1 knockout

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (4)

  • Response Rate

    6 months

  • Progression free survival - PFS

    Up to 12 months

  • Overall Survival - OS

    Death

  • Peripheral blood circulating tumor DNA

    8 weeks

Study Arms (3)

Therapeutic vaccine

ACTIVE COMPARATOR

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.

Biological: Therapeutic vaccine

Therapeutic vaccine plus PD-1 knockout

EXPERIMENTAL

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.

Biological: Therapeutic vaccineBiological: PD-1 Knockout T Cells

PD-1 knockout T cells

ACTIVE COMPARATOR

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.

Biological: PD-1 Knockout T Cells

Interventions

Therapeutic vaccineBIOLOGICAL

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 vaccineTherapeutic vaccine plus PD-1 knockout
PD-1 Knockout T CellsBIOLOGICAL

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 cellsTherapeutic vaccine plus PD-1 knockout

Eligibility Criteria

Age18 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate cancer is only presented in male
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, 510080, China

RECRUITING

Professor Size Chen

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Size Chen, MD, PhD

    The First Affiliated Hospital of Guangdong Pharmaceutical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Size Chen, MD, PhD

CONTACT

+861371095639313710956393@139.com

Zhizhou Huang, MSc

CONTACT

+8613268258980hzhizhou@sina.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 16, 2018

Study Start

February 22, 2018

Primary Completion

February 22, 2021

Study Completion

August 30, 2021

Last Updated

May 16, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)