Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of HER2-positive Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Interventions
- DRUG Trastuzumab
- BIOLOGICAL Dendritic Cell (DC1) Vaccine
- DRUG Pepinemab
- BIOLOGICAL T-Cell therapy
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-05-31 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05378464 shows while recruiting
NCT05378464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (88% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for HER2-positive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05378464's enrollment target sits among peer trials
28 44th of 58 higher than 13 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Phase 1/1b Study of IAM1363 in HER2 Cancers
RECRUITING · Phase 1
-
PRE-I-SPY Phase I/Ib Oncology Platform Program
RECRUITING · Phase 1
-
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
RECRUITING · Phase 1
-
HER-2 B Cell Peptide Vaccine
RECRUITING · Phase 1
-
HER2 Vaccine for Locally Advanced Breast Cancer
RECRUITING · Phase 1
-
Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03471117 · 28 participants · Phase 4
Pioglitazone to Reduce Sympathetic Overactivity in CKD Patients
- NCT03523975 · 28 participants · Phase 1
Venetoclax, Lenalidomide and Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma
- NCT03608631 · 28 participants · Phase 1
iExosomes in Treating Participants With Metastatic Pancreas Cancer With KrasG12D Mutation
- NCT03810651 · 28 participants · Early Phase 1
Pencil Beam Scanning in Patients With Renal Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI