OncRef

Clinical Trial: NCT05809752

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute
Information Provided By:H. Lee Moffitt Cancer Center and Research Institute
Last Update Posted:2026-09-15

Study Overview

Brief Summary

The purpose of this study is to learn about the effects of the study treatment, Dendritic Cell Vaccine (DCV), to find the highest dose of the study treatment that can be given safely to Breast Cancer patients with Leptomeningeal Disease

Official Title

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC)

Conditions

Leptomeningeal Disease, Triple Negative Breast Cancer, HER2-positive Breast Cancer

Intervention / Treatment

  • Biological: Dendritic Cell Vaccine

Other Study ID Numbers

  • MCC-21262

Start Date (Actual)

2023-08-22

Primary Completion Date (Actual)

2026-05-13

Study Completion Date (Estimated)

2027-08

Enrollment (Actual)

15

Study Type

Interventional

Phase

Phase 1