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Relapsed/Refractory Acute Myeloid Leukemia (AML)Phase 1NCT07084584

ENLIGHT-AML - An Open-label, Study of GB3226 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

A Phase 1 study testing GB3226 in people with Relapsed/Refractory Acute Myeloid Leukemia (AML), run by Galecto Biotech AB.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The ENLIGHT-AML study is a Phase 1, open-label, dose-escalation and expansion study of GB3226 in the treatment of relapsed or refractory acute myeloid leukaemia Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GB3226
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
10 Jun 2026to 10 Oct 2029
Phase
Phase 1
Are there results?
None posted in the registry

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

None listed.

Who cannot join

  • Patients meeting any of the following criteria are NOT eligible for study participation:
  • Diagnosis
  • Diagnosis of active acute promyelocytic leukemia. (APML).
  • Diagnosis of chronic myelogenous leukemia (CML) in blast crisis.
  • Active CNS disease (cytology, such as any blasts on cytospin, or radiography). Patients who have cleared CNS disease by at least one negative tap prior to dosing may be enrolled, and prophylactic intrathecal chemotherapy may be continued while on trial (see inclusion criteria 12).
  • Detectable human immunodeficiency virus (HIV) viral load within the previous 6 months. Patients with a known history of HIV 1/2 antibodies must have viral load testing prior to study enrolment.
Show all 35Show fewer
  • Hepatitis B (defined as hepatitis B virus [HBV] surface antigen positive and HBV core antibody positive, or positive HBV deoxyribonucleic acid [DNA]).
  • Hepatitis C (defined as positive hepatitis C [HCV] antibody with reflex to positive HCV ribonucleic acid [RNA]).
  • NB: Patients with controlled HIV, Hep B and Hep C disease will not be excluded from study enrolment.
  • Pregnancy and Breast-Feeding
  • Pregnant or nursing women. Negative serum pregnancy tests are required during Screening and a negative serum or urine pregnancy test is required within 72 hours prior to receiving the first study drug administration, in females of childbearing potential. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Concurrent Conditions
  • Cardiac Disease:
  • Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled/unstable angina, congestive heart failure (New York Heart Association Classification Class ≥III), life-threatening, uncontrolled hypertension or arrhythmia, ischemic or severe valvular heart disease, cerebrovascular accident, or transient ischemic attack.
  • Mean QTcF ≥470 ms on triplicate ECG. Appropriate corrections for patients with bundle branch block and ventricular paced rythms are allowed.
  • Gastrointestinal Disease:
  • Any gastrointestinal issue of the upper GI tract likely to affect oral drug absorption or ingestion (e.g., gastric bypass, gastroparesis, etc).
  • Cirrhosis with a Child-Pugh score of B or C.
  • Signs or symptoms of acute or chronic GVHD (Harris 2016, Lee 2015) requiring systemic treatment within 4 weeks of enrolment. All transplant patients must have been off all systemic immunosuppressive therapy and calcineurin inhibitors for at least 4 weeks prior to enrolment. Patients may be on physiological doses of steroids (≤10 mg/day prednisone equivalent).
  • Concurrent malignancy in the previous 2 years, with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ, melanoma in situ) treated with potentially curative therapy, or concurrent low-grade lymphoma, that is asymptomatic and lacks bulky disease and shows no evidence of progression, and for which the patient is not receiving any systemic therapy or radiation.
  • Concurrent malignancy must be in complete remission (CR) or no evidence of disease (NED) during this timeframe.
  • Pre-existing disorder predisposing the patient to a serious or life-threatening infection (e.g. cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder, or cytopenias not related to AML).
  • Acute or chronic systemic fungal, bacterial, viral, or other infection which is uncontrolled.
  • Major surgery within 4 weeks prior to the first dose of GB3226.
  • History of or any concurrent condition, therapy, laboratory abnormality, or allergy to excipients (see formulation details in Investigator Brochure) that in the Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.
  • Concomitant Medications and Interventions
  • Any commercially available or investigational antileukemic therapy other than GB3226, with the following exceptions:
  • Short-term administration of corticosteroids and/or hydroxyurea for cytoreduction. For treatment of life-threatening events, alternative cytoreductive agents as judged by the treating physician after consultation with study physician may be applied.
  • Intrathecal chemotherapy for CNS prophylaxis is permitted, at the treating physician's discretion. In the Phase 1a evaluable cohort, CNS prophylaxis may continue starting in C2D1.
  • Receipt of an investigational agent within 30 days of starting GB3226, unless inclusion criteria 10-14, then the longer period may be applied. Patients may continue with noninterventional follow-up from previous clinical studies.
  • The following Exclusions apply related to concomitant use of CYP3A4 inhibitors or inducers:
  • Phase 1a:
  • Cohort A: Concurrent use of weak, moderate, and strong inhibitors or inducers of CYP3A4. Patients who were receiving CYP3A4 inhibitors/inducers must have discontinued the medication at least 7 days or 5 half-lives which-ever is longer, for CYP3A4 inhibitors or 14 days or 5 half-lives, which-ever is longer for CYP3A4 inducers prior to enrolment
  • Cohort B: Concurrent use of moderate and strong CYP3A4 inhibitors/inducers (except for systemic itraconazole, ketoconazole, posaconazole, or voriconazole, which should have been started at least 7 days prior to enrolment). Patients who were receiving other CYP3A4 inhibitors/inducers must have discontinued the medication at least 7 days or 5 half-lives which-ever is longer, for CYP3A4 inhibitors or 14 days or 5 half-lives, which-ever is longer for CYP3A4 inducers prior to enrolment
  • Cohort C: Concurrent use of moderate, and strong inhibitors or inducers of CYP3A4, except for isovuconazole or fluconazole, which should have been started at least 7 days prior to enrolment. Patients who were receiving other CYP3A4 inhibitors/inducers must have discontinued the medication at least 7 days or 5 half-lives which-ever is longer, for CYP3A4 inhibitors or 14 days or 5 half-lives, which-ever is longer for CYP3A4 inducers prior to enrolment

About this study

Official title: ENLIGHT-AML: A Phase 1, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of GB3226 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

The ENLIGHT-AML study is a Phase 1, open-label, dose-escalation and expansion study of GB3226 in the treatment of relapsed or refractory acute myeloid leukaemia

Read the detailed description

Study GB3226-DEV-001 is a Phase 1, open-label, dose-escalation and expansion study of GB3226 in the treatment of relapsed or refractory acute myeloid leukemia. Adult patients aged ≥18 years of age are planned to be enrolled. GB3226 will be administered once daily orally (PO) in 28-day cycles, with the first study drug dose administered on Cycle 1 Day 1 (C1D1). Up to a total of three separate patient cohorts will be explored (GB3226 without a CYP3A4 inhibitor, GB3226 with a strong CYP3A4 inhibitor and, if indicated, a cohort of GB3226 with a moderate CYP3A4 inhibitor).

Being tested
GB3226
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GB3226Drug

    GB3226: Dual inhibitor of ENL-YEATS and FLT3 pathways Administration: Oral, daily dosing in 28-day cycles

Study groups in NCT07084584
Study groupRoleWhat they receive
Cohort A - GB3226 without CYP34A Inhibitor therapyExperimentalCohort A: Patients must not be receiving any weak, moderate, or strong CYP3A4 inhibitors/inducers. Patients who were receiving a CYP3A4 inhibitor/inducer must have discontinued the medication at least 7 days prior to enrolment
Receives: Drug: GB3226
Cohort B - GB3226 in combination with a strong CYP34A InhibitorExperimentalCohort B: Patients must be receiving a strong CYP3A4 inhibitor for antifungal prophylaxis (e.g. parconazole, itraconazole, ketoconazole, or voriconazole) for at least 7 days prior to enrolment and while on GB3226 treatment. Patients must not be receiving any other strong CYP3A4 inhibitors/inducers.
Receives: Drug: GB3226
Cohort C - GB3226 in combination with a moderate CYP34A InhibitorExperimentalCohort C: Patients must be receiving a moderate CYP3A4 inhibitor for antifungal prophylaxis (e.g., isavuconazole, fluconazole) for at least 7 days prior to enrolment and while on GB3226. Patients must not be receiving any other strong or moderate CYP3A4 inhibitors/inducers
Receives: Drug: GB3226

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of dose-limiting toxicities (Phase 1)

    Incidence of dose-limiting toxicities events identified

    Measured: 28 Days

  2. To assess the Incidence of adverse and serious adverse events related to GB3226

    Incidence of adverse events as reported by investigators.

    Measured: 28 Days

  3. To characterize the PK parameters of GB3226

    Plasma concentrations of GB3226

    Measured: 28 Days

  4. To assess the complete remission and complete remission with partial hematologic recovery rate (Phase 2)

    Number of subjects in complete remission or complete remission with partial hematologic recovery

    Measured: 28 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2025
  2. Study start10 Jun 2026 (estimated)
  3. Primary completion10 Jun 2029 (estimated)
  4. Study completion10 Oct 2029 (estimated)

Why it stopped: Study withdrawn due to business priority changes

Resources

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
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07084584
Sponsor's protocol ID
GB3226-DEV-001
Other IDs
ENLIGHT-AML
Status last verified
Jul 2025
First submitted
17 Jul 2025
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GB3226 in people with Relapsed/Refractory Acute Myeloid Leukemia (AML), run by Galecto Biotech AB.

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 0 inclusion and 35 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: withdrawn, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of dose-limiting toxicities (Phase 1) (time frame: 28 Days). 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?

On the ClinicalTrials.gov record for NCT07084584.

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 6 Jul 2026.

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