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NCT06146257 · ClinicalTrials.gov registry record · Phase 1
A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by GluBio Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 8
- Study locations
NCT06146257: Recruiting Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by GluBio Therapeutics.
NCT06146257 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by GluBio Therapeutics. The registered enrollment target is 48 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (59% lower). The trial reports 8 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06146257, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by GluBio Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 8
- Study locations
Study Summary
Study GLB-001-01 is a first-in-human (FIH), Phase 1, open-label, dose escalation and expansion clinical study of GLB-001 in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The dose escalation part (Phase 1a) of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 administered orally. Approximately 24 participants (up to 42 participants) may be enrolled in Phase 1a of the study. The dose expansion part (Phase 1b) will be followed to understand the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Up to 24 participants (12 participants per dose level) may be enrolled in Phase 1b of the study.
Primary Outcome
Dose-limiting toxicity is defined as the treatment emergent adverse events (TEAEs) meeting protocol specified DLT criteria and occurring within the DLT assessment period.
Conditions Studied
Interventions
- DRUG GLB-001
Study Locations (8)
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Memorial Sloan Kettering Cancer Center-David H. Koch Center - New York
- Icahn School of Medicine at Mount Sinai - New York
California
- City of Hope Medical Center - Duarte
- University of California Irvine - Irvine
Kansas
- University of Kansas Medical Center Research Institute, Inc. - Kansas City
- Alliance for Multispecialty Research, LLC - Merriam
Texas
- University of Texas M. D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-01-11 |
| Est. Completion | 2026-10-08 |
| Phase | Phase 1 |
What NCT06146257 shows while recruiting
NCT06146257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (59% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which GLB-001 is the first listed.
NCT06146257 lists 8 locations in 4 states (New York, California, Kansas).
Frequently Asked Questions
What is clinical trial NCT06146257 about?
NCT06146257 is a clinical study titled "A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes". Study GLB-001-01 is a first-in-human (FIH), Phase 1, open-label, dose escalation and expansion clinical study of GLB-001 in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The...
What is the current status of trial NCT06146257?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2024-01-11. Estimated completion is 2026-10-08.
What conditions does trial NCT06146257 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes.
What interventions are being tested in trial NCT06146257?
The interventions under investigation include: GLB-001 (DRUG).
Who is sponsoring clinical trial NCT06146257?
This trial is sponsored by GluBio Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06146257 being conducted?
This trial has 8 study locations across California, Kansas, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06146257's enrollment target sits among peer trials
48 155th of 306 higher than 151 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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