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NCT06435351 · ClinicalTrials.gov registry record · Early Phase 1
Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy
A Early Phase 1 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06435351: Recruiting Early Phase 1 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT06435351 is a Early Phase 1 study of Breast Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 16 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06435351, a Early Phase 1 study of Breast Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.
Primary Outcome
Successful production and administration of DC1 priming vaccination sequence in greater than 60% of patients enrolled.
Conditions Studied
Interventions
- PROCEDURE Leukapheresis
- BIOLOGICAL Dendritic Cell (DC) Vaccine
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-06-12 |
| Est. Completion | 2029-05 |
| Phase | Early Phase 1 |
What NCT06435351 shows while recruiting
NCT06435351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Leukapheresis is the first listed.
NCT06435351 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06435351 about?
NCT06435351 is a clinical study titled "Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy". This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.
What is the current status of trial NCT06435351?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2024-06-12. Estimated completion is 2029-05.
What conditions does trial NCT06435351 study?
This clinical trial studies the following conditions: Breast Cancer, Triple Negative Breast Cancer.
What interventions are being tested in trial NCT06435351?
The interventions under investigation include: Leukapheresis (PROCEDURE), Dendritic Cell (DC) Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06435351?
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 NCT06435351 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT06435351's enrollment target sits among peer trials
16 1135th of 1224 higher than 82 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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