OncoMatch/Clinical Trials/NCT05378464
Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer
Is NCT05378464 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Dendritic Cell (DC1) Vaccine and T-Cell therapy for her2-positive breast cancer.
Treatment: Dendritic Cell (DC1) Vaccine · Trastuzumab · Pepinemab · T-Cell therapy — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
HER2 positive breast cancer is defined by tumor tissue HER2 overexpression and or tumor HER2 amplification per ASCO/CAP criteria
Required: HER2 (ERBB2) amplification
HER2 positive breast cancer is defined by tumor tissue HER2 overexpression and or tumor HER2 amplification per ASCO/CAP criteria
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: her2-targeted therapy (trastuzumab) — metastatic
Cannot have received: adoptive cell transfer therapy
Lab requirements
Blood counts
Must have normal organ and marrow function as defined in protocol within 14 days of registration.
Kidney function
Must have normal organ and marrow function as defined in protocol within 14 days of registration.
Liver function
Must have normal organ and marrow function as defined in protocol within 14 days of registration.
Cardiac function
Left ventricular ejection fraction above institutional lower limit of normal (by echocardiogram or MUGA scan)
Must have normal organ and marrow function as defined in protocol within 14 days of registration. Left ventricular ejection fraction above institutional lower limit of normal (by echocardiogram or MUGA scan)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05378464 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior adoptive cell transfer therapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 amplification is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages