A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)

PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 22, 2023

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Leptomeningeal DiseaseTriple Negative Breast CancerHER2-positive Breast Cancer
Interventions
BIOLOGICAL

Dendritic Cell Vaccine

"Intrathecal (IT) dendritic cell vaccine (DCV) will be administered once every week. As per standard procedures of IT chemotherapy or antibody administration it is administered over 5 -10 minutes or at 1 ml/minute while monitoring the patient under sterile conditions. In general, to assure delivery of the DCVs into the ventricular space and compensate for dead space in the Ommaya, the delivery of IT DCV cells is followed by the administration of 2.5 mls of saline. In general there is a maximum volume of 10 mls of DCVs."

Trial Locations (3)

10065

NOT_YET_RECRUITING

Memorial Sloan Kettering Cancer Center, New York

14263

NOT_YET_RECRUITING

Roswell Park Comprehensive Cancer Center, Buffalo

33612

RECRUITING

Moffitt Cancer Center, Tampa

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER