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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06146257
The ClinicalTrials.gov registry entry for NCT06146257 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 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 (59% lower). The listed sponsor is GluBio Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 4 distinct geographic areas - top geographies include 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.
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