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

PHASE1RecruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

May 31, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
HER2-positive Breast Cancer
Interventions
BIOLOGICAL

Dendritic 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.

DRUG

Trastuzumab

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.

DRUG

Pepinemab

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

BIOLOGICAL

T-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.

Trial Locations (1)

33612

RECRUITING

Moffitt Cancer Center, Tampa

All Listed Sponsors
collaborator

Vaccinex Inc.

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER