Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New antibody GEN3018 enters first human tests for tough blood cancers

NCT ID NCT07384715

Disease control Sponsor: Genmab Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 7 times

Summary

This early-stage trial is testing a new antibody drug called GEN3018 in people whose acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) has come back or stopped responding to treatment. The main goal is to check safety and find the right dose. Up to 78 participants will receive the drug by IV, and the study will monitor them closely for side effects and any signs that the drug is working.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GEN3018 (an antibody given by IV infusion)
What this could lead to
If it works, this could point toward a new treatment option for people with hard-to-treat blood cancers like AML and MDS.
What could go wrong
This is a very early, first-in-human trial focused on safety, not effectiveness. The drug may not work or could have serious side effects. Only 78 people will be enrolled, so results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 78 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia Higher-risk myelodysplastic syndrome R/R AML R/R HR-MDS

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aarhus Universitetshospital - Skejby

    RECRUITING

    Aarhus, 8200, Denmark

  • Copenhagen Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Hospital Clínic de Barcelona

    NOT_YET_RECRUITING

    Barcelona, 08036, Spain

  • Hospital Universitari Vall d'Hebron

    NOT_YET_RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitari i Politècnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    NOT_YET_RECRUITING

    Madrid, 28041, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.