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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: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by University of Virginia.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Escalation phase participants only
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 |
What NCT07270978 shows while recruiting
NCT07270978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (80% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT07270978's enrollment target sits among peer trials
23 233rd of 306 higher than 72 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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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