RecruitingPhase 1NCT05809752

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

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)


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

18 participants

Start Date

Aug 22, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing the safety of a dendritic cell vaccine in people with breast cancer (triple-negative or HER2-positive) that has spread to the membranes surrounding the brain and spinal cord — a rare and serious condition called leptomeningeal disease. **You may be eligible if...** - You have triple-negative breast cancer (TNBC) or HER2-positive breast cancer - You have been diagnosed with leptomeningeal disease, confirmed by cancer cells found in spinal fluid or characteristic MRI findings - You show signs or symptoms consistent with leptomeningeal involvement **You may NOT be eligible if...** - You have a different breast cancer subtype (e.g., ER/PR-positive and HER2-negative) - You do not have confirmed leptomeningeal disease - You are too unwell to participate in a Phase I study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDendritic 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.


Locations(3)

Moffitt Cancer Center

Tampa, Florida, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05809752


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