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NCT05378464 · ClinicalTrials.gov registry record · Phase 1

Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer

A Phase 1 study of HER2-positive Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Recruiting
Registry status
Phase 1
Development phase
28
Enrollment target
1
Study location

NCT05378464 is a Phase 1 study of HER2-positive Breast Cancer that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 28 participants, below the 239-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05378464, a Phase 1 study of HER2-positive Breast Cancer, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

RECRUITING
Registry status
Phase 1
Development phase
28 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with HER2 positive breast cancer.

Conditions Studied

HER2-positive Breast Cancer

Interventions

  • DRUG Trastuzumab
  • BIOLOGICAL Dendritic Cell (DC1) Vaccine
  • DRUG Pepinemab
  • BIOLOGICAL T-Cell therapy

Study Locations (1)

Florida

  • Moffitt Cancer Center - Tampa

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2022-05-31
Est. Completion 2026-12
Phase Phase 1

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

502 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05378464

The ClinicalTrials.gov registry entry for NCT05378464 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (88% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Trastuzumab is the first listed.

NCT05378464 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT05378464 about?

NCT05378464 is a clinical study titled "Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer". The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell (DC1) study vaccine given in combination with pepinemab added to standard of care therapy, trastuzumab to help people with HER2 positive breast cancer.

What is the current status of trial NCT05378464?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2022-05-31. Estimated completion is 2026-12.

What conditions does trial NCT05378464 study?

This clinical trial studies the following conditions: HER2-positive Breast Cancer.

What interventions are being tested in trial NCT05378464?

The interventions under investigation include: Trastuzumab (DRUG), Dendritic Cell (DC1) Vaccine (BIOLOGICAL), Pepinemab (DRUG), T-Cell therapy (BIOLOGICAL).

Who is sponsoring clinical trial NCT05378464?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05378464 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.