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Study of GLB-001 for Relapsed or Refractory AML or Higher-Risk MDS

This study is testing a new oral medicine called GLB-001 for people with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) that has come back or not responded to previous treatments. The main goal is to find a safe dose of GLB-001 and see how well your body tolerates it. Researchers will also look at how the drug moves through your body and if it shows any early signs of helping your condition. You may be eligible if you are at least 18 years old and willing to follow the study schedule. The study plans to enroll up to 48 participants, but the current recruitment status is unclear.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know you are receiving GLB-001. It will involve a dose escalation phase to find the best dose, followed by an expansion phase, and plans to enroll up to 48 participants.
What's involved
You will take GLB-001 orally according to a set schedule. You will need to attend study visits and follow other protocol requirements.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 2 years after starting the study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06146257

A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes

Recruiting
PHASE1Ages 18+InterventionalTreatment
GluBio Therapeutics Inc.
~48 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:GLB-001

At a glance

Recruiting sites
3 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting Toxicity (DLT)
Measured over Up to 28 days after first dose of study treatment in Phase 1a
+3 more outcomes measured

Conditions

Acute Myeloid Leukemia
Myelodysplastic Syndromes

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic Syndrome

Where it's being run

8 sites across 4 states
New York3
California2
Kansas2
Texas1

Study leadership

  • Gang Lu, Ph.D. · STUDY_DIRECTOR · GluBio Therapeutics Inc.

Who to contact

Kimberly Glen
[email protected]
984-260-8186
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants is ≥ 18 years of age at the time of signing the Informed Consent Form (ICF).
Participants must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Participants are willing and able to adhere to the study visit schedule and other protocol requirements.
Participants with histologically or cytologically confirmed AML including de novo AML or secondary AML transformed from MDS according to 2022 World Health Organization (WHO) criteria classification, or with histologically or cytologically confirmed HR-MDS.
R/R AML and R/R HR-MDS who have failed or are ineligible for all available therapies which may provide clinical benefit.
Participants must have the following screening laboratory values:
Total white blood cell count (WBC) \< 25 x 10\^9/L prior to the first dose of the study drug.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN), unless considered due to extensive leukemic liver involvement, in which case AST and ALT can be ≤ 5.0 x ULN.
Serum total bilirubin ≤ 1.5 x ULN, unless considered due to Gilbert's syndrome, in which case serum total bilirubin \< 3 x ULN.
Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gault equation. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated.
International normalized ratio (INR) ≤ 1.5 x ULN and active partial thromboplastin time (aPTT) ≤ 1.5 x ULN.
Life expectancy ≥ 12 weeks.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
Female Participants of child-bearing potential must have a negative serum or urine pregnancy test at screening and at pre-dose on Cycle 1 Day 1 (C1D1).

Exclusion

Participants with acute promyelocytic leukemia (APML).
Participants with known leukemic involvement in central nervous system (CNS).
Receipt of anticancer medications/therapies within 5 half-lives or 28 days before the first administration of the study drug.
Participants with unresolved clinically significant non-hematologic toxicities of ≥ Grade 2 AE from prior therapies with exception of residual alopecia.
Participants with chronic graft versus host disease (GVHD) requiring systemic immunosuppressive therapy.
Participants with active malignancies other than AML or MDS.
Participants who have undergone major surgery ≤ 4 weeks prior to the first dose of the study drug.
Participants with immediately life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection (bacterial and/or fungal), uncontrolled bleeding, and/or uncontrolled disseminated intravascular coagulation.
Participants with known chronic, active infection of hepatitis B virus (HBV), hepatitis C virus C (HCV), human immunodeficiency virus (HIV).
Participants unable to swallow oral medications, or Participants with clinically significant diarrhea, vomiting or malabsorption felt limited absorption of orally administered medications.
Participants with any other significant medical conditions, any other conditions, laboratory abnormality, or psychiatric illness which place the Participants at unacceptable risk if he/she were to participate in the study or that would hamper the Participants understanding of the study, or would prevent the Participant from complying with the study.
Medications or supplements that are known to be strong and moderate inhibitors or inducers of CYP450 isozyme 3A4 (CYP3A4) and/or P-glycoprotein (P-gp), or strong inhibitors or inducers of CYP450 isozyme 2C8 (CYP2C8) within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
Pregnant or lactating women.

What this trial measures

  • Dose-limiting Toxicity (DLT)Up to 28 days after first dose of study treatment in Phase 1a

    Dose-limiting toxicity is defined as the treatment emergent adverse events (TEAEs) meeting protocol specified DLT criteria and occurring within the DLT assessment period.

  • Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD)Up to 2 years

    Maximum tolerated dose is defined as the highest dose level at which no more than 1 of 6 DLT-evaluable participants experienced a DLT. If MTD is not established at the end of dose escalation phase, the maximum safety dose will be defined as Maximum administered dose.

  • Incidence of Adverse Events (AEs)Up to 2 years

    Adverse Events will be graded according to the National Cancer Institute Common Terminology Criteria for AE (NCI CTCAE) version 5.0.

  • Recommended Phase 2 Dose (RP2D)Up to 2 years

    Recommended phase 2 dose based on the totality of data across dosing cohorts in the dose escalation and expansion phases of the study including PK, PD, safety and efficacy outcomes.