Home › Trials › NCT07384715
Clinical trial Recruiting at 6 sites Phase 1 Interventional Ages 18 and up

GEN3018 for relapsed or treatment‑resistant acute myeloid leukemia and higher‑risk MDS

Official title: An Open-Label, Multicenter, First-in-Human Trial of GEN3018 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome

Run by Genmab · NCT07384715 · Data updated 2026-11-12

This trial will test a new antibody drug called GEN3018 in adults whose AML or higher‑risk MDS has relapsed or not responded to prior treatments.

More Acute Myeloid Leukemia trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment78 (estimated)
SponsorGenmab
Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations9 sites (Aarhus, Denmark and 8 other locations)
StatusRecruiting
StartedFebruary 16, 2026
Main results expectedOctober 18, 2029
Study endsApril 20, 2030
Registry record updatedNovember 4, 2026
Trial IDNCT07384715 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with relapsed or refractory AML or higher‑risk MDS, bone marrow blasts ≥5%, ECOG performance status 0–2, acceptable laboratory values, and prior therapy failure who can undergo required bone marrow sampling are the intended candidates.

Probably not a fit

Patients with newly diagnosed disease, bone marrow blasts below 5%, ECOG performance status >2, significant uncontrolled comorbidities, or inability to undergo bone marrow sampling are unlikely to be eligible or to benefit from this early‑phase trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

GEN3018 is a novel antibody given to adults with relapsed or refractory acute myeloid leukemia (AML) or higher‑risk myelodysplastic syndrome (HR‑MDS) in a first‑in‑human, open‑label Phase 1 trial. Part 1 uses dose escalation to find a safe dose and characterize safety, pharmacokinetics, immunogenicity, and tolerability, while Part 2 refines the recommended dose(s) for further testing. Up to 78 participants across multiple centers will receive GEN3018 and be monitored with clinical exams, laboratory tests, and bone marrow sampling for preliminary anti‑tumor activity and adverse events. Collected data will guide dose selection and design of later studies.

Why it matters

Potential benefit: If GEN3018 is safe and active, it could produce remissions or longer disease control for people with relapsed or refractory AML or HR‑MDS who have limited treatment options.

How similar studies have gone: Antibody‑based therapies in AML/MDS (for example gemtuzumab ozogamicin) have produced benefit in some patient subsets, but many novel antibodies are untested in humans and outcomes remain uncertain.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

All Participants:

* Be at least 18 years of age at the time of signing informed consent form (ICF).
* Participant's life expectancy at screening is judged to be at least 3 months.
* Must have fresh bone marrow samples collected at screening.
* Bone marrow (BM) blasts ≥ 5% at screening.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2.
* Has acceptable laboratory test results during the screening period

Participants with R/R AML:

* Relapsed or refractory AML, either de novo or secondary, and must have failed all conventional therapies.
* Relapsed or refractory to at least one prior line of therapy.

Participants with R/R HR-MDS:

* Diagnosed with high- or very-high risk MDS according to International Prognostic Scoring System (IPSS-R) (score of \> 4.5 ie, high or very high) or World Health Organization (WHO) 2022 classification (ie, MDS-IB1 or MDS-IB2).
* Refractory or relapsed after hypomethylating agents (HMAs) (such as azacitidine or decitabine).

Key Exclusion Criteria:

All Participants:

* Diagnosis of acute promyelocytic leukemia (APL).
* Presence of extramedullary AML at screening.
* Prior autologous or allogenic hematopoietic stem cell transplant (HSCT) within 3 months prior to initiation of trial treatment.
* Active graft-versus-host disease.
* History of severe immune-related adverse events.
* Treatment with anti-cancer agent (eg, small molecule, antibody, chemotherapy, radiation therapy), or major surgery within 2 weeks prior to the first dose of GEN3018.

Other protocol-defined Inclusion and Exclusion criteria may apply.

Where it's running

  • Aarhus Universitetshospital - Skejby
    Aarhus, Denmark, Denmark     Recruiting
  • Copenhagen Rigshospitalet
    Copenhagen, Denmark, Denmark     Recruiting
  • Hospital Universitari Vall d'Hebron
    Barcelona, Barcelona, Spain     Recruiting
  • Hospital Clínic de Barcelona
    Barcelona, Barcelona, Spain     Recruiting
  • Hospital Universitario 12 de Octubre
    Madrid, Madrid, Spain     Recruiting
  • Hospital Universitari i Politècnic La Fe
    Valencia, Valencia, Spain     Recruiting
Show 3 more locations
  • ASST Papa Giovanni XXIII
    Bergamo, Italy     Not yet recruiting
  • Istituto Clinico Humanitas
    Milan, Italy     Not yet recruiting
  • Azienda Ospedaliero Universitaria Pisana
    Pisa, Italy     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Acute Myeloid Leukemia 453Higher-risk Myelodysplastic Syndrome 3Genmab 14
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.