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NCT07270978 · ClinicalTrials.gov registry record · Phase 1
Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT07270978 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 23 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07270978, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to understand the safety and estimate the efficacy of combining anti-CD3 x anti-CD33 bispecific antibody (CD33Bi) armed fresh peripheral blood mononuclear cells (CD33Bi FPBMC) for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) where they still have detectable disease ("MRD+") after some treatment. Participants receive 4 weekly doses of CD33 FPBMC by intravenous infusion followed by 4-6 weeks of standard treatment with a hypomethylating agent (type of treatment such as decitabine or azacitidine) and possibly a drug called venetoclax. This is considered 1 cycle of study treatment and may be repeated up to 4 times during the study.
Conditions Studied
Interventions
- DRUG CD33 FPBMC
Study Locations (1)
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2026-02 |
| Est. Completion | 2031-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07270978
The ClinicalTrials.gov registry entry for NCT07270978 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (80% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which CD33 FPBMC is the first listed.
NCT07270978 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT07270978 about?
NCT07270978 is a clinical study titled "Phase Ib Study of CD33 FPBMC in Patients With MRD+ AML or MDS". The purpose of this study is to understand the safety and estimate the efficacy of combining anti-CD3 x anti-CD33 bispecific antibody (CD33Bi) armed fresh peripheral blood mononuclear cells (CD33Bi FPBMC) for patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) where they sti...
What is the current status of trial NCT07270978?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2026-02. Estimated completion is 2031-06.
What conditions does trial NCT07270978 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm.
What interventions are being tested in trial NCT07270978?
The interventions under investigation include: CD33 FPBMC (DRUG).
Who is sponsoring clinical trial NCT07270978?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07270978 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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