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NCT03661424 · ClinicalTrials.gov registry record · Phase 1
BATs in Patients With Breast Cancer and Leptomeningeal Metastases
A Phase 1 study, sponsored by University of Virginia.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03661424 is a Phase 1 study that was terminated before completion, run by University of Virginia. The registered enrollment target is 3 participants.
The verdict
NCT03661424, a Phase 1 study, was terminated before completion, sponsored by University of Virginia.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study uses bi-specific antibody (HER2Bi) armed activated T-cells (HER2 BATs) to target breast cancer cells that have metastasized to the membranes surrounding the brain and spinal cord. This is known as leptomeningeal metastases. Two doses will be evaluated in order to determine a safe dose. Study treatment includes a test dose of HER2 BATs followed by 8 weekly infusions of HER2 BATs at the assigned dose level. Before, during and after study treatment, participants will be monitored objectively by brain MRIs and clinically through physical and neurological exams, and blood and cerebrospinal fluid will be collected to evaluate immune responses.
Interventions
- DRUG HER2 BATs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-02-26 |
| Est. Completion | 2021-12-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03661424
The ClinicalTrials.gov registry entry for NCT03661424 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HER2 BATs is the first listed.
NCT03661424 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03661424 about?
NCT03661424 is a clinical study titled "BATs in Patients With Breast Cancer and Leptomeningeal Metastases". This study uses bi-specific antibody (HER2Bi) armed activated T-cells (HER2 BATs) to target breast cancer cells that have metastasized to the membranes surrounding the brain and spinal cord. This is known as leptomeningeal metastases. Two doses will be evaluated in order to determine a safe dose. S...
What is the current status of trial NCT03661424?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2019-02-26. Estimated completion is 2021-12-14.
What interventions are being tested in trial NCT03661424?
The interventions under investigation include: HER2 BATs (DRUG).
Who is sponsoring clinical trial NCT03661424?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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