Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

June 12, 2024

Primary Completion Date

May 31, 2029

Study Completion Date

May 31, 2029

Conditions
Breast CancerTriple Negative Breast Cancer
Interventions
PROCEDURE

Leukapheresis

"Removal of white blood cells (leukocytes) from the blood. The dendritic cells are harvested from the white blood cells that are collected and trained to recognize the specific abnormal proteins found in the tumor sample.~One needle is inserted in each arm. An apheresis machine removes blood from the vein in one arm, separates and retains the leukocytes from the blood, and then returns the rest of the blood to the other arm."

BIOLOGICAL

Dendritic Cell (DC) Vaccine

"The vaccine will be given intranodally (inguinal or axillary) under ultrasound guidance using a dose of 40-50 million cells three times spaced 2 weeks apart for the initial priming sequence.~3 doses of the priming vaccines are given once every 2 weeks. 2 booster shots (if available) will be given 6 months and 12 months following completion of initial priming vaccines."

Trial Locations (1)

33612

RECRUITING

Moffitt Cancer Center, Tampa

All Listed Sponsors
lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER