DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 26, 2022

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Triple Negative Breast CancerHER2-negative Breast Cancer
Interventions
BIOLOGICAL

HER2 - primed Dendritic cells

"Dendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs.~Participants will be treated at the following dose levels:~Dose level 1: HER2 - primed Dendritic cells dose 10-20 million Dose level 2: HER2 - primed Dendritic cells dose 30-50 million Dose level 3: HER2 - primed Dendritic cells dose 80-100 million"

BIOLOGICAL

HER3 - primed Dendritic cells

"Dendritic cell will be administered at ultra-sound guided injections. Participants will receive 8 intratumoral injections. These injections will be administered twice per week per week (given 3 days apart). Participants will receive alternating injections (3 days apart) of HER2-primed followed by HER3-primed DCs.~Participants will be treated at the following dose levels:~Dose level 1: HER3 - primed Dendritic cells dose 10-20 million Dose level 2: HER3 - primed Dendritic cells dose 30-50 million Dose level 3: HER3 - primed Dendritic cells dose 80-100 million"

Trial Locations (1)

33612

RECRUITING

Moffitt Cancer Center, Tampa

All Listed Sponsors
collaborator

The Shulas' Foundation

UNKNOWN

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER