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NCT05809752 · ClinicalTrials.gov registry record · Phase 1
A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)
A Phase 1 study of Triple Negative Breast Cancer and HER2-positive Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 3
- Study locations
NCT05809752: Recruiting Phase 1 study of Triple Negative Breast Cancer and HER2-positive Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT05809752 is a Phase 1 study of Triple Negative Breast Cancer and HER2-positive Breast Cancer that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 18 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05809752, a Phase 1 study of Triple Negative Breast Cancer and HER2-positive Breast Cancer, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 3
- Study locations
Study 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
Primary Outcome
Maximum tolerated dose of intrathecal dendritic cell vaccine is defined as the highest dose of vaccine that does not cause undesirable side effects/dose limiting toxicity (DLT). To evaluate safety, the study team will monitor toxicities continuously and the study will be halted if an excessive number of toxicities are encountered.
Conditions Studied
Interventions
- BIOLOGICAL Dendritic Cell Vaccine
Study Locations (3)
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Memorial Sloan Kettering Cancer Center - New York
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-08-22 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
What NCT05809752 shows while recruiting
NCT05809752 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Dendritic Cell Vaccine is the first listed.
NCT05809752 reports a single indexed study location in New York, Florida.
Frequently Asked Questions
What is clinical trial NCT05809752 about?
NCT05809752 is a clinical study titled "A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)". 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
What is the current status of trial NCT05809752?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2023-08-22. Estimated completion is 2026-03.
What conditions does trial NCT05809752 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer, HER2-positive Breast Cancer, Leptomeningeal Disease.
What interventions are being tested in trial NCT05809752?
The interventions under investigation include: Dendritic Cell Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05809752?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05809752 being conducted?
This trial has 3 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05809752's enrollment target sits among peer trials
18 105th of 118 higher than 14 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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