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NCT02348320

Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy

Completed Phase 1 Last updated 1 July 2020
What this trial tests

Phase 1 trial testing Personalized polyepitope DNA vaccine in Triple Negative Breast Cancer in 18 participants. Completed in 12 March 2020.

Timeline
17 June 2015
Primary endpoint
12 March 2020
12 March 2020

Quick facts

Lead sponsorWashington University School of Medicine
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment18
Start date17 June 2015
Primary completion12 March 2020
Estimated completion12 March 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

18 and older, female only, with Triple Negative Breast Cancer or Triple-Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase 1 open-label study to evaluate the safety and immunogenicity of a personalized polyepitope DNA vaccine strategy. The personalized polyepitope DNA vaccines will be formulated as naked plasmid DNA vaccines. The hypothesis of this study is that personalized polyepitope DNA vaccines will be safe for human administration and capable of generating measurable CD8 T cell responses to mutant tumor-specific antigens.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Towards personalized, tumour-specific, therapeutic vaccines for cancer.
    Hu Z, Ott PA, Wu CJ. · · 2018 · cited 772× · PMID 29226910 · DOI 10.1038/nri.2017.131
  2. Cancer DNA vaccines: current preclinical and clinical developments and future perspectives.
    Lopes A, Vandermeulen G, Préat V. · · 2019 · cited 277× · PMID 30953535 · DOI 10.1186/s13046-019-1154-7
  3. Mechanisms of immune evasion in breast cancer.
    Bates JP, Derakhshandeh R, Jones L, Webb TJ. · · 2018 · cited 206× · PMID 29751789 · DOI 10.1186/s12885-018-4441-3
  4. The Role of Neoantigens in Naturally Occurring and Therapeutically Induced Immune Responses to Cancer.
    Ward JP, Gubin MM, Schreiber RD. · · 2016 · cited 201× · PMID 26922999 · DOI 10.1016/bs.ai.2016.01.001
  5. Preclinical and clinical development of neoantigen vaccines.
    Li L, Goedegebuure SP, Gillanders WE. · · 2017 · cited 162× · PMID 29253113 · DOI 10.1093/annonc/mdx681
  6. Neoantigen prediction and computational perspectives towards clinical benefit: recommendations from the ESMO Precision Medicine Working Group.
    De Mattos-Arruda L, Vazquez M, Finotello F, Lepore R, et al · · 2020 · cited 126× · PMID 32610166 · DOI 10.1016/j.annonc.2020.05.008
  7. CD8<sup>+</sup> T cell-based cancer immunotherapy.
    Chen Y, Yu D, Qian H, Shi Y, et al · · 2024 · cited 63× · PMID 38685033 · DOI 10.1186/s12967-024-05134-6
  8. Breast Cancer Neoantigens Can Induce CD8<sup>+</sup> T-Cell Responses and Antitumor Immunity.
    Zhang X, Kim S, Hundal J, Herndon JM, et al · · 2017 · cited 63× · PMID 28619968 · DOI 10.1158/2326-6066.cir-16-0264

Verify or expand the search:

Other recruiting trials for Triple Negative Breast Cancer

Currently open trials in the same condition.

Other Washington University School of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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