OncoMatch/Clinical Trials/NCT05809752
A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)
Is NCT05809752 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Dendritic Cell Vaccine for leptomeningeal disease.
Treatment: Dendritic Cell Vaccine — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression <10% (<10%)
A tumor can be considered a TNBC if the ER or PR is <10%
Required: PR (PGR) expression <10% (<10%)
A tumor can be considered a TNBC if the ER or PR is <10%
Required: HER2 (ERBB2) overexpression
HER2+BC per ASCO/CAP guidelines
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: treatment specifically administered to treat LMD
Exception: within the last 2 weeks or 5 half-lives of the agent, whichever is less
Receiving other treatments specifically administered to treat LMD within the last 2 weeks or 5 half-lives of the agent, whichever is less
Cannot have received: immunotherapy
Exception: within the last four weeks
The use of any immunotherapy within the last four weeks
Cannot have received: phase I agent or agent which significantly and unequivocally penetrates the CSF (e.g., high-dose methotrexate, thiotepa, high-dose ara-C) (high-dose methotrexate, thiotepa, high-dose cytarabine)
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
Cannot have received: live vaccine
Exception: within 30 days prior to the first dose of study drug
Has received a live vaccine within 30 days prior to the first dose of study drug
Lab requirements
Blood counts
Demonstrate adequate organ function as defined in protocol. All screening labs should be performed with 14 days of treatment initiation.
Kidney function
Demonstrate adequate organ function as defined in protocol. All screening labs should be performed with 14 days of treatment initiation.
Liver function
Demonstrate adequate organ function as defined in protocol. All screening labs should be performed with 14 days of treatment initiation.
Demonstrate adequate organ function as defined in protocol. All screening labs should be performed with 14 days of treatment initiation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
- Roswell Park Comprehensive Cancer Center · Buffalo, New York
- Memorial Sloan Kettering Cancer Center · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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