RecruitingPhase 1NCT05378464

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

Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

28 participants

Start Date

May 31, 2022

Study Type

INTERVENTIONAL

Conditions

HER2-positive Breast Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of immune therapies for HER2-positive metastatic breast cancer — including a personalized immune cell treatment (adoptive T cell therapy), a vaccine that trains the immune system to target HER2, and two antibody drugs (trastuzumab and pepinemab) — to see if this combination can better control the cancer. **You may be eligible if...** - You have confirmed HER2-positive metastatic breast cancer - You are a candidate for trastuzumab (Herceptin) therapy - You have at least one measurable area of cancer on imaging - Your cancer has progressed after prior standard HER2-targeted treatments - Your organ function (heart, blood, liver, kidneys) is adequate **You may NOT be eligible if...** - Your heart function is impaired - You have active brain metastases that are symptomatic or growing - You have significant autoimmune disease - You are currently pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDendritic Cell (DC1) Vaccine

Participants will receive a DC1 vaccine injection at 1.0-2.0 x 10\^7 cells, either to groin lymph notes or to tumor if accessible once a week for 3 weeks on days 1, 8 and 15. Participants will receive DC1 vaccine boosters every 3 weeks x 3.

DRUGTrastuzumab

Participants will receive trastuzumab 8 mg/kg by IV week 1, then 6 mg/kg by IV beginning week 4 and continuing every 3 weeks until disease progression or intolerable toxicity.

DRUGPepinemab

Participants will receive pepinemab 20 mg/kg by IV beginning week 1 and continuing every 3 weeks until disease progression or intolerable toxicity.

BIOLOGICALT-Cell therapy

Participants will receive IL-15 expanded CD4 T cells infusion by IV Day 1 at week 8, 2 weeks from last DC1 vaccine, and IL-7 expanded CD4 T cells infusion IV at week 8 day 8.