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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 (May 2026). This Phase 1 trial studies multiple treatments including Dendritic Cell (DC1) Vaccine and T-Cell therapy for her2-positive breast cancer.

Phase 1RecruitingH. Lee Moffitt Cancer Center and Research InstituteNCT05378464Data as of May 2026

Treatment: Dendritic Cell (DC1) Vaccine · Trastuzumab · Pepinemab · T-Cell therapyThe 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.

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Extracted eligibility criteria

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

Max 3 prior lines

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

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