Personalized Cancer Vaccine (PCV) Strategy in Triple Negative Breast Cancer Patients

StatusNot Yet Recruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later May 31, 2030 → Jul 31, 2030
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Record History

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  1. Start date: Aug 1, 2026 to Oct 1, 2026
    • Primary completion pushed from May 31, 2030 to Jul 31, 2030
    • Study completion pushed from Apr 30, 2035 to Jun 30, 2035
    • Site contact updated
    v5
  2. Primary endpoint(s) modifiedv4 Show 8 more changesShow less
    • Start date: Jun 30, 2026 to Aug 1, 2026
    • Primary completion pushed from Apr 8, 2030 to May 31, 2030
    • Study completion pushed from Mar 9, 2035 to Apr 30, 2035
    • Interventions: AB248 (CD8-selective IL-2 mutein fusion protein) (Drug), Carboplatin (Drug), Cyclophosphamide (Drug), Doxorubicin (Drug), Paclitaxel… to AB248 (Drug), Carboplatin (Drug), Cyclophosphamide (Drug), Doxorubicin (Drug), Paclitaxel (Drug), Pembrolizumab (Drug), Personalized cancer…
    • Eligibility criteria expanded, about 80 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site contact updated
    • Study title expanded, about 1 word
  3. Start date: Mar 31, 2026 to Jun 30, 2026
    • Primary completion pushed from Jan 8, 2030 to Apr 8, 2030
    • Study completion pushed from Dec 9, 2034 to Mar 9, 2035
    v3
  4. Site contact updatedv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine (PCV) strategy with or without CD8-selective IL-2 mutein fusion protein in patients with triple negative breast cancer undergoing neoadjuvant chemoimmunotherapy.
Trial Details
NCT Number NCT07300475
Lead Sponsor Washington University School of Medicine
Conditions
(from sponsor)		 Triple Negative Breast Cancer
Related terms Triple Negative Breast Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov