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A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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)

NCT05809752•H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed diagnosis of TNBC or HER2+BC per ASCO/CAP guidelines . A tumor can be considered a TNBC if the ER or PR is \<10%.
•Trial participants must have a diagnosis of LMD. They must have the presence of malignant cells in the CSF (CSF+; note now cytology is considered diagnostic of LMD if the cytology is read as positive or suspicious; OR characteristic radiographic abnormalities (see below) of LMD). Signs and symptoms of LMD in and of themselves are not sufficient for inclusion.
•Patients must have an Eastern Cooperative Oncology Group performance scale of ≤ 3.
•Coincident Brain or Spinal cord metastases are allowed if these are stable and do not require local therapy at the time of enrollment. Individuals with previously treated stable Brain metastases are eligible to participate.
•Stereotactic Radiosurgery (SRS) and/or prior radiotherapy is permitted \> 2 weeks prior to initial Dendritic Cell (DC) vaccine dose. A follow up brain MRI should be obtained prior to DC vaccine to determine stability of the lesions. An interval of at least 4 weeks after the end of whole brain radiation or for any surgical resection of brain lesions is permitted.
•Life expectancy of ≥ 8 weeks.
•Demonstrate adequate organ function as defined in protocol. All screening labs should be performed with 14 days of treatment initiation.
•Provision of signed and dated informed consent form.
•Corticosteroids at doses equivalent to 8 mg dexamethasone daily for symptom control are acceptable. This should be minimized wherever possible.

Exclusion Criteria

•Patients with systemic disease are eligible and will be managed as detailed in Section 6.3.1.
•Pregnancy test: negative serum or urine pregnancy test at screening for women of childbearing potential. Must be repeated once-monthly during treatment. Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 90 days after last treatment administration, if the risk of conception exists.
•The patient has an Ommaya reservoir or equivalent device which allows routine access to CSF and administration of DC1s.
•Receiving other treatments specifically administered to treat LMD within the last 2 weeks or 5 half-lives of the agent, whichever is less. However, all other treatments to control systemic disease or bulk CNS disease will be eligible, provided the therapy is not a phase I agent, an agent which significantly and unequivocally penetrates the CSF (e.g., high-dose methotrexate, thiotepa, high-dose ara-C) per PI discretion.
•The use of any immunotherapy within the last four weeks.
•Patients with a ventriculoperitoneal or ventriculoatrial shunt must have an on/off device in their shunt systems to be eligible for the study. Patients must be able to tolerate shunt closure for \~4 hours without development of clinical signs of increased intracranial pressure. Patients unable to tolerate shunt closure for \~4 hours will not be eligible for the study.
•Unable or unwilling to have a contrast-enhanced brain MRI.
•Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin,squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
•Has an active infection requiring systemic therapy which in the opinion of the investigator will increase the risk to the patient.
•Had major surgical procedure, or significant traumatic injury within two weeks. Ommaya placement is allowed.
+9 more criteria

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

Key Dates

Start Date

August 22, 2023

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

January 8, 2026

Enrollment

ESTIMATED participants

Conditions

Leptomeningeal DiseaseTriple Negative Breast CancerHER2-positive Breast Cancer

Interventions

Dendritic Cell Vaccine

BIOLOGICAL

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Advanced Breast CancerMetastatic Breast Cancer+3 more

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Triple Negative Breast CancerResidual Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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