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NCT06026657 · ClinicalTrials.gov registry record · Phase 1
Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer
A Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and HER2-Negative Breast Carcinoma, sponsored by Margaret Gatti-Mays.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT06026657: Recruiting Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and HER2-Negative Breast Carcinoma, sponsored by Margaret Gatti-Mays.
NCT06026657 is a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and HER2-Negative Breast Carcinoma that is actively recruiting participants, run by Margaret Gatti-Mays. The registered enrollment target is 42 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06026657, a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and HER2-Negative Breast Carcinoma, is actively recruiting participants, sponsored by Margaret Gatti-Mays.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib/II trial tests the safety, best dose and how well gemcitabine and ex vivo expanded allogenic universal donor TGFBi NK cells with or without naxitamab work for the treatment of patients with GD2 expressing, HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. TGFBi NK cells are manufactured cells that are a part of your natural immunity. NK cells can recognize missing or incorrect proteins on tumor cells and then eliminate these tumor cells and TGFBi NK cells are created to be able to better kill the tumor cells. Naxitamab is a monoclonal antibody that targets GD2, which is a protein or sugar present on tumor cells but not very commonly found on normal cells. This antibody helps draw the attention of the immune system to the tumor cells that have GD2 to help attack the tumor cells. Giving gemcitabine and TGFBi NK cells with or without naxitamab may kill more tumor cells in patients with metastatic GD2 expressing, HER2 negative breast cancer.
Primary Outcome
Will be summarized descriptively with reporting of any dose limiting toxicities (DLTs) in these initial patients. In addition, to DLTs, serious adverse events (SAEs) and immune related adverse events of interest will be reported. Will be summarized descriptively and graphically, with reporting the outcome measures indicated along with two-tailed 95% confidence intervals (CIs). Number and frequency of patients experiencing each adverse event (AE) type and grade will tabulated, among patients eval
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Gemcitabine
- BIOLOGICAL Naxitamab
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2024-04-02 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT06026657 shows while recruiting
NCT06026657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (75% lower).
The record links to 2 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06026657 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06026657 about?
NCT06026657 is a clinical study titled "Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells With or Without Naxitamab (Danyelza) for the Treatment of Patients With Metastatic, GD2 Expressing, HER2 Negative Breast Cancer". This phase Ib/II trial tests the safety, best dose and how well gemcitabine and ex vivo expanded allogenic universal donor TGFBi NK cells with or without naxitamab work for the treatment of patients with GD2 expressing, HER2 negative breast cancer that has spread from where it first started (primary...
What is the current status of trial NCT06026657?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2024-04-02. Estimated completion is 2026-12-31.
What conditions does trial NCT06026657 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma.
What interventions are being tested in trial NCT06026657?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Gemcitabine (DRUG), Naxitamab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06026657?
This trial is sponsored by Margaret Gatti-Mays, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06026657 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06026657's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 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.
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