Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)

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

First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS) (NCT07384715) is a Phase 1 interventional studying R/R AML and R/R HR-MDS, sponsored by Genmab. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The drug that will be investigated in the trial is an antibody, GEN3018. Since this is the first trial of GEN3018 in humans, the main purpose is to evaluate safety. In addition to safety, the trial will determine the recommended GEN3018 dose(s) to be tested in a larger group of participants and assess preliminary anti-tumor activity of GEN3018. GEN3018 will be studied in refractory (resistant to treatment) or relapsed (disease has returned) acute myeloid leukemia (also known as R/R AML) and refractory or relapsed higher-risk myelodysplastic syndrome (also known as R/R HR-MDS). The trial consists of 2 parts: 1. Part 1 Dose Escalation will test increasing doses of GEN3018 to identify a safe dose level to be tested in the next part 2. Part 2 Dose Refinement will further test the GEN3018 dose(s) determined from the Dose Escalation. Up to 78 participants may be treated in this trial (up to 60 participants in Part 1; up to 18 participants in Part 2). For an individual participant in the trial, the estimated treatment duration will be up to 1 year. Participation in the trial will require regular scheduled visits to the site. At site visits, there will be various tests (such as blood draws) to monitor whether the treatment is safe and effective. Participants will also be contacted every 3 months after treatment ends to monitor how they are doing. All participants in the trial will receive active drug (ie, GEN3018); no one will be given placebo.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For R/R AML, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 78 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused R/R AML subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Key Who May Qualify: All Participants: - Be at least 18 years of age at the time of signing willing to sign a consent form 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 Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BIOLOGICAL

GEN3018

Intravenous (IV) infusion.

Locations (9)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Aarhus Universitetshospital - Skejby

Aarhus, Denmark

Copenhagen Rigshospitalet

Copenhagen, Denmark

Charite Campus Virchow-Klinikum

Berlin, Germany

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Klinikum der Universität München Großhadern

Munich, Germany

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07384715), the sponsor (Genmab), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07384715 clinical trial studying?

Who can participate in NCT07384715?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07384715?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07384715. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07384715. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.