Acute Myeloid LeukemiaPhase 1NCT06146257
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 testing GLB-001 in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by GluBio Therapeutics Inc. at 8 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- GLB-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Jan 2024to 8 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 3 recruiting
- Terminated
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Brian Ball, MD, 626-218-4784, brball@coh.org
- Terminated
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
- Terminated
University of California Irvine
Irvine, California, 92697
- Recruiting
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
Jesus Gonzalez Lugo, MD, 913-588-4138, jgonzalezlugo@kumc.edu
- Terminated
Alliance for Multispecialty Research, LLC
Merriam, Kansas, 66204
- Terminated
Memorial Sloan Kettering Cancer Center-David H. Koch Center
New York, New York, 10021
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Lewis Silverman, MD, 212-241-5520, Lewis.silverman@mssm.edu
About this study
Official title: A First-in-human, Phase 1, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy 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 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.
Read the detailed description
A standard 3+3 dose-escalation design will be applied to evaluate a set of several dose levels to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of GLB-001 in R/R AML or R/R HR-MDS patients who are eligible for DLT evaluation. The actual dose-escalation magnitude or dosing frequency may be adjusted based on the available PK and safety data in human.
After the MTD or MAD of GLB-001 is defined in Phase 1a, 1 or 2 dose levels will be selected for expansion per safety review committee (SRC) recommendation, approximately 12 patients will be enrolled per dose level. Recommended phase 2 dose (RP2D) will be selected based on the results of PK, PD, safety and efficacy in the dose escalation and expansion study.
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Being tested
- GLB-001
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLB-001Drug
Also called GLB-C183-A-2
Administered orally according to the assigned treatment schedule
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation of GLB-001 as a Monotherapy in Participants with R/R AML and R/R HR-MDS-Phase 1a | Experimental | Part 1a (Dose Escalation) of the study will enroll R/R AML and R/R HR-MDS participants and will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001 administered orally, and determine the maximum tolerated dose/maximum administered dose (MTD/MAD) in R/R AML or R/R HR-MDS patients who are eligible for dose limiting toxicity (DLT) evaluation. Receives: Drug: GLB-001 |
| Dose Expansion of GLB-001 as a Monotherapy in Participants with R/R AML and R/R HR-MDS-Phase 1b | Experimental | Part 1b (Dose Expansion) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for R/R AML and R/R HR-MDS participants. Receives: Drug: GLB-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity (DLT)
Dose-limiting toxicity is defined as the treatment emergent adverse events (TEAEs) meeting protocol specified DLT criteria and occurring within the DLT assessment period.
Measured: Up to 28 days after first dose of study treatment in Phase 1a
Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD)
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.
Measured: Up to 2 years
Incidence of Adverse Events (AEs)
Adverse Events will be graded according to the National Cancer Institute Common Terminology Criteria for AE (NCI CTCAE) version 5.0.
Measured: Up to 2 years
Recommended Phase 2 Dose (RP2D)
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.
Measured: Up to 2 years
Secondary outcomes (34)
GLB-001 Pharmacokinetics-AUC0-last
Area under the concentration-time curve from zero to the last measurable concentration.
Measured: Up to 2 years
GLB-001 Pharmacokinetics-AUC0-24
Area under the concentration-time curve from 0 to 24 hours.
Measured: Up to 2 years
GLB-001 Pharmacokinetics-AUC0-∞
Area under the concentration-time curve from 0 to infinity.
Measured: Up to 2 years
GLB-001 Pharmacokinetics-Cmax
Maximum plasma concentration.
Measured: Up to 2 years
GLB-001 Pharmacokinetics-Tmax
The time to reach maximum concentration.
Measured: Up to 2 years
GLB-001 Pharmacokinetics-T1/2
Terminal half-life.
Measured: Up to 2 years
GLB-001 Pharmacokinetics-Vd/F
Apparent volume of distribution.
Measured: Up to 2 years
GLB-001 Pharmacokinetics-LI
Linear index.
Measured: Up to 2 years
GLB-001 Pharmacokinetics-CL/F
Apparent clearance.
Measured: Up to 2 years
GLB-C183-A-2R (Isomer of GLB-001) Pharmacokinetics-AUC0-last
Area under the concentration-time curve from zero to the last measurable concentration.
Measured: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-AUC0-24
Area under the concentration-time curve from 0 to 24 hours.
Measured: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-AUC0-∞
Area under the concentration-time curve from 0 to infinity.
Measured: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-Cmax
Maximum plasma concentration.
Measured: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-Tmax
The time to reach maximum concentration.
Measured: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-T1/2
Terminal half-life.
Measured: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-Vd/F
Apparent volume of distribution.
Measured: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-LI
Linear index.
Measured: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-CL/F
Apparent clearance.
Measured: Up to 2 years
Complete Remission Without Minimal Residual Disease (CRMRD-) Rate in Participants with Acute Myeloid Leukemia (AML)
CRMRD- rate is defined as the percent of participants with minimal residual disease negative complete remission. CRMRD- will be assessed by the 2022 European Leukemia Net Response Criteria (2022 ELN) for AML .
Measured: Up to 2 years
Complete Remission (CR) Rate in Participants with AML
CR rate is defined as the percent of participants whose best response is CR. CR will be assessed by 2022 ELN for AML.
Measured: Up to 2 years
CR with Incomplete Hematologic Recovery (CRi) Rate in Participants with AML
CRi rate is defined as the percent of participants whose best response is CRi. CRi will be assessed by 2022 ELN for AML.
Measured: Up to 2 years
CR with Partial Hematological Recovery (CRh) Rate in Participants with AML
CRh rate is defined as the percent of participants whose best response is CRh. CRh will be assessed by 2022 ELN for AML.
Measured: Up to 2 years
Morphologic Leukemia-free State (MLFS) Rate in Participants with AML
MLFS rate is defined as the percent of participants with the best response of morphologic leukemia-free state. MLFS will be assessed by 2022 ELN for AML.
Measured: Up to 2 years
Partial Remission (PR) Rate in Participants with AML
PR rate is defined as the percent of participants whose best response is PR. PR will be assessed by 2022 ELN for AML.
Measured: Up to 2 years
Duration of Remission or Response (DOR) in Participants with AML
For participants with best response of any of CRMRD-, CR, CRh, CRi, PR, and MLFS, DOR is measured from the time when criteria (2022 ELN for AML) for the best response of any of CRMRD-, CR, CRh, CRi, PR, and MLFS are first met (whichever is first recorded) until the first date at which relapse, or progressive disease is objectively documented assessment.
Measured: Up to 2 years
Time to Remission or Response (TOR) in Participants with AML
Time to onset of first remission or response is defined as the time interval from the date of first dose and the earliest date any remission or response [any CRs (including CR, CRh and CRi) or PR] is observed.
Measured: Up to 2 years
Stable Disease (SD) Rate in Participants with AML
SD rate is defined as the percent of participants with the best response of stable disease. SD will be assessed by 2022 ELN for AML.
Measured: Up to 2 years
CR Rate in Participants with Higher Risk Myelodysplastic Syndromes (HR-MDS)
CR rate is defined as the percent of participants whose best response is CR. CR will be assessed by 2006 Modified International Working Group (IWG) MDS response criteria.
Measured: Up to 2 years
PR Rate in Participants with HR-MDS
PR rate is defined as the percent of participants whose best response is PR. PR will be assessed by 2006 Modified IWG MDS response criteria.
Measured: Up to 2 years
SD Rate in Participants with HR-MDS
SD rate is defined as the percent of participants with the best response of stable disease. SD will be assessed by 2006 Modified IWG MDS response criteria.
Measured: Up to 2 years
DOR in Participants with HR-MDS
For participants with best response of any of CR, marrow CR, or PR, DOR is measured from the time when criteria (2006 Modified IWG MDS response criteria) for the best response of any of CR, marrow CR, or PR are first met (whichever is first recorded) until the first date at which relapse or progressive disease is objectively documented assessment.
Measured: Up to 2 years
TOR in Participants with HR-MDS
Time to onset of first remission or response is defined as the time interval from the date of first dose of GLB-001 and the earliest date any remission or response [any CRs (including CR, marrow CR or PR)] is observed.
Measured: Up to 2 years
Progression-free Survival (PFS) in Participants with AML or HR-MDS
PFS is defined as the time from the first dose of GLB-001 to the first occurrence of relapse or progression or death from any cause.
Measured: Up to 2 years
Overall Survival (OS) in Participants with AML or HR-MDS
OS is defined as the time from the first dose of GLB-001 to death due to any cause.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start11 Jan 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion8 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GluBio Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gang Lu, Ph.D., Study director, GluBio Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146257
- Sponsor's protocol ID
- GLB-001-01
- Status last verified
- Apr 2026
- First submitted
- 10 Nov 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Phase 1, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT06146257
- Acronym / sponsor ID
- GLB-001-01
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- GluBio Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 8 Oct 2026 (estimated)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A standard 3+3 dose-escalation design will be applied to evaluate a set of several dose levels to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of GLB-001 in R/R AML or R/R HR-MDS patients who are eligible for DLT evaluation. The actual dose-escalation magnitude or dosing frequency may be adjusted based on the available PK and safety data in human.
After the MTD or MAD of GLB-001 is defined in Phase 1a, 1 or 2 dose levels will be selected for expansion per safety review committee (SRC) recommendation, approximately 12 patients will be enrolled per dose level. Recommended phase 2 dose (RP2D) will be selected based on the results of PK, PD, safety and efficacy in the dose escalation and expansion study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation of GLB-001 as a Monotherapy in Participants with R/R AML and R/R HR-MDS-Phase 1a | Experimental | Drug: GLB-001Part 1a (Dose Escalation) of the study will enroll R/R AML and R/R HR-MDS participants and will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001 administered orally, and determine the maximum tolerated dose/maximum administered dose (MTD/MAD) in R/R AML or R/R HR-MDS patients who are eligible for dose limiting toxicity (DLT) evaluation. |
| Dose Expansion of GLB-001 as a Monotherapy in Participants with R/R AML and R/R HR-MDS-Phase 1b | Experimental | Drug: GLB-001Part 1b (Dose Expansion) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for R/R AML and R/R HR-MDS participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLB-001Also: GLB-C183-A-2Administered orally according to the assigned treatment schedule | Drug | Dose Escalation of GLB-001 as a Monotherapy in Participants with R/R AML and R/R HR-MDS-Phase 1a, Dose Expansion of GLB-001 as a Monotherapy in Participants with R/R AML and R/R HR-MDS-Phase 1b |
Primary outcome
Dose-limiting Toxicity (DLT)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
34 secondary outcomes
GLB-001 Pharmacokinetics-AUC0-last
Time frame: Up to 2 years
GLB-001 Pharmacokinetics-AUC0-24
Time frame: Up to 2 years
GLB-001 Pharmacokinetics-AUC0-∞
Time frame: Up to 2 years
GLB-001 Pharmacokinetics-Cmax
Time frame: Up to 2 years
GLB-001 Pharmacokinetics-Tmax
Time frame: Up to 2 years
GLB-001 Pharmacokinetics-T1/2
Time frame: Up to 2 years
GLB-001 Pharmacokinetics-Vd/F
Time frame: Up to 2 years
GLB-001 Pharmacokinetics-LI
Time frame: Up to 2 years
GLB-001 Pharmacokinetics-CL/F
Time frame: Up to 2 years
GLB-C183-A-2R (Isomer of GLB-001) Pharmacokinetics-AUC0-last
Time frame: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-AUC0-24
Time frame: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-AUC0-∞
Time frame: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-Cmax
Time frame: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-Tmax
Time frame: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-T1/2
Time frame: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-Vd/F
Time frame: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-LI
Time frame: Up to 2 years
GLB-C183-A-2R Pharmacokinetics-CL/F
Time frame: Up to 2 years
Complete Remission Without Minimal Residual Disease (CRMRD-) Rate in Participants with Acute Myeloid Leukemia (AML)
Time frame: Up to 2 years
Complete Remission (CR) Rate in Participants with AML
Time frame: Up to 2 years
CR with Incomplete Hematologic Recovery (CRi) Rate in Participants with AML
Time frame: Up to 2 years
CR with Partial Hematological Recovery (CRh) Rate in Participants with AML
Time frame: Up to 2 years
Morphologic Leukemia-free State (MLFS) Rate in Participants with AML
Time frame: Up to 2 years
Partial Remission (PR) Rate in Participants with AML
Time frame: Up to 2 years
Duration of Remission or Response (DOR) in Participants with AML
Time frame: Up to 2 years
Time to Remission or Response (TOR) in Participants with AML
Time frame: Up to 2 years
Stable Disease (SD) Rate in Participants with AML
Time frame: Up to 2 years
CR Rate in Participants with Higher Risk Myelodysplastic Syndromes (HR-MDS)
Time frame: Up to 2 years
PR Rate in Participants with HR-MDS
Time frame: Up to 2 years
SD Rate in Participants with HR-MDS
Time frame: Up to 2 years
DOR in Participants with HR-MDS
Time frame: Up to 2 years
TOR in Participants with HR-MDS
Time frame: Up to 2 years
Progression-free Survival (PFS) in Participants with AML or HR-MDS
Time frame: Up to 2 years
Overall Survival (OS) in Participants with AML or HR-MDS
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gang Lu, Ph.D. study director
GluBio Therapeutics Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLB-001 in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by GluBio Therapeutics Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Glen (984-260-8186, Kimberly.glen@glubiotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicity (DLT) (time frame: Up to 28 days after first dose of study treatment in Phase 1a). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.