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New antibody drug tested for tough blood cancers – but trial stopped early

NCT ID NCT04824794

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 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new experimental drug called GEN3014 (HexaBody-CD38) in people with multiple myeloma and other blood cancers that had returned or become resistant to treatment. The main goal was to check safety and find the right dose. The trial was terminated early, so the full results are not available.

What this could mean

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

Active substance
GEN3014 (HexaBody-CD38) and daratumumab
What this could lead to
If successful, this could lead to a new treatment option for people with blood cancers that have returned or stopped responding to other therapies.
What could go wrong
This was a very early (Phase 1/2) trial, so the drug might not work or could have serious side effects. The trial was terminated, meaning it stopped early, so results are limited.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

130 people

The number who actually took part.

Started

Mar 2021

Finished

Jul 2025

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 * Must have fresh bone marrow samples collected at Screening for RRMM, R/R AML, and R/R DLBCL with suspected bone marrow involvement. * Dose Escalation phase, Expansion Part A (for MM and AML) and Expansion Part B- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0, 1, or 2. Expansion Part A (for DLBCL): ECOG PS 0 or 1. * Has acceptable laboratory test results during the Screening period. * A woman of reproductive potential must agree to use adequate contraception during the trial and for 12 months after the last GEN3014 or daratumumab SC administration. * A woman of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) at Screening and additionally, for Expansion Part B, within 72 hours of the first dose of study treatment prior to dosing. * A woman must agree not to donate eggs (ova, oocytes) for assisted reproduction during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC. * A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control and all men must not donate sperm during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC. Specific for RRMM: * Must have documented multiple myeloma as defined by the criteria below and have evidence of disease progression on the most recent prior treatment regimen based on IMWG criteria: * Prior documentation of monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy-proven plasmacytoma and, * Measurable disease at baseline as defined by any of the following: * Immunoglobulin (Ig) G, IgA, IgD, or IgM myeloma: Serum M-protein level ≥0.5 g/dL (≥5 g/L) or urine M protein level ≥200 mg/24 hours or, * Light chain myeloma: Serum Ig free light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio. Note: Participants with RRMM must have exhausted standard therapies, at the investigator's discretion. * For anti-CD38 mAb-naive RRMM Cohort: Participant received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory imide drug (IMiD) in any order, or is double refractory to a PI and an IMiD; or participant received ≥ 2 prior lines of therapy if 1 of those lines included a combination of PI and IMiD. Note: Participants should not have received any anti-CD38 antibody. * Anti-CD38 mAb-naive RRMM participants will be enrolled from ex-US countries. * Dose Escalation phase - For anti-CD38 mAb-treated RRMM Cohort: Participant has received at least 2 prior lines of therapy and must have discontinued daratumumab or isatuximab for at least 4 weeks prior to the first dose of GEN3014. Note: Participants should not have received any other anti-CD38 antibody except daratumumab or isatuximab. Specific for R/R AML: * Relapsed or refractory AML, both de novo or secondary; must have failed all conventional therapy. Acute promyelocytic leukemia (APL) is excluded from this trial. Note: Relapse is defined by BM blasts ≥5% in participants who have been in CR previously, or reappearance of blasts in the blood, or development of extramedullary AML. Refractory is defined as not being able to achieve a CR after the initial therapy. * Participant with relapsed AML who received at least 2 prior therapies for AML with the exception of hydroxyurea. * Participant with refractory AML who received at least 1 prior line of therapy for AML with the exception of hydroxyurea. * Participant's life expectancy at Screening is judged to be at least 3 months. Specific for DLBCL: * Expansion phase: Relapsed or refractory DLBCL, both de novo or histologically transformed. Participants with R/R DLBCL must have exhausted standard therapies, at the investigator's discretion. * Expansion phase: Received at least 2 prior lines of systemic therapy, with 1 being a CD20-containing chemoimmunotherapy. * Expansion phase: Have at least 1 measurable site of disease as per Lugano criteria. * Expansion phase: Must have available archival or fresh tumor tissue or both to submit to a central laboratory for CD38 assay. Key Exclusion Criteria * Prior treatment with any CD38-directed therapies (eg, daratumumab, isatuximab, CD38 chimeric antigen receptor T cell (CAR-T), bispecific antibody (Ab)) in anti-CD38 mAb-naive RRMM Cohort. Note: Prior daratumumab or isatuximab exposure is allowed for anti-CD38 mAb-treated RRMM participants in the Dose Escalation and anti-CD38 mAb-refractory RRMM Cohort in the Expansion Part A. * Treatment with an anti-cancer agent, chemotherapy, radiation therapy, or major surgery within 2 weeks prior to the first dose of study treatment (Dose Escalation and Expansion Part A) or randomization (Expansion Part B). * Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of study treatment (Dose Escalation and Expansion Part A) or randomization (Expansion Part B). * Cumulative dose of corticosteroids more than the equivalent of ≥140 mg of prednisone within 2-week period before the first dose of study treatment (Dose Escalation and Expansion Part A) or maximum cumulative dose of dexamethasone 160 mg within 28 days of randomization (Expansion Part B). * Has clinically significant cardiac disease. * Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy. * Primary central nervous system (CNS) tumor or known CNS involvement at Screening. * Has known history/positive serology for hepatitis B. * Known medical history or ongoing hepatitis C infection that has not been cured. * Known history of seropositivity of human immunodeficiency virus (HIV) (Dose Escalation and Expansion Part A) or to be positive for HIV with details in the protocol (Expansion Part B). * Currently receiving any other investigational agents. * A woman who is pregnant or breast-feeding, or who is planning to become pregnant while enrolled in this trial or within 12 months after the last dose of study treatment. * A man who plans to father a child while enrolled in this trial or within 12 months after the last dose of study treatment. Specific Exclusion Criteria for RRMM: * Prior allogeneic hematopoietic stem cell transplant (HSCT). * Autologous HSCT within 3 months of the first dose of GEN3014. Specific Exclusion Criteria for R/R AML: * \<5% blasts in blood or bone marrow at Screening. * White blood cell (WBC) counts ≥50,000/microliter (μL) in peripheral blood that cannot be controlled by hydroxyurea prior to the first dose of GEN3014. * Prior autologous HSCT. * Allogenic HSCT within 3 months of the first dose of GEN3014. * Active graft-versus-host-disease requiring immunosuppressive treatment. Any immunosuppressive medication (eg, calcineurin inhibitors) must be stopped ≥4 weeks prior to the first dose of GEN3014. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia diffuse large B-cell lymphoma plasma cell myeloma Recurrence refractory plasma cell neoplasm relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

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

Acute myeloid leukemia (AML) Diffuse large B cell lymphoma (DLBCL) Relapsed or refractory multiple myeloma (RRMM)

Contacts and locations

Locations

  • ARENSIA Exploratory Medicine LLC

    Tbilisi, Georgia

  • Aalborg Universitet

    Aalborg, Denmark

  • Ahepa University General hospital

    Thessaloniki, Greece

  • Alexandra General Hospital

    Athens, Greece

  • Arensia Exploratory Medicine

    Kyiv, Ukraine

  • Auckland Cancer Trials Centre

    Grafton, New Zealand

  • Beacon Hospital

    Petaling Jaya, Malaysia

  • CHRU de Lille

    Lille, France

  • CHRU de Nantes

    Nantes, France

  • Chonnam National University Hwasun Hospital

    Gwangju, South Korea

  • Christchurch Hospital

    Christchurch, New Zealand

  • Erasmus MC

    Rotterdam, Netherlands

  • Evangelismos Hospital NKUA

    Athens, Greece

  • FNO - Fakultni nemocnice Ostrava

    Poruba, Czechia

  • Fakultni Nemocnice Brno

    Brno, Czechia

  • Fakultni Nemocnice Hradec Kralove FNHK

    Nový Hradec Králové, Czechia

  • Fakultni Nemocnice Olomouc (FNOL)

    Olomouc, Czechia

  • Gachon University Gil Medical Center

    Seongnam, South Korea

  • Hospital Ampang

    Ampang, Malaysia

  • Hospital Sultanah Aminah

    Johor Bahru, Malaysia

  • Hospital Umum Sarawak

    Kuching, Malaysia

  • Institute of Oncology, ARENSIA Exploratory Medicine

    Chisinau, Moldova

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601, United States

  • Karolinska Institute

    Huddinge, Sweden

  • Klinika za hematologiju KCUS

    Sarajevo, Bosnia and Herzegovina

  • Maastricht UMC

    Maastricht, Netherlands

  • Makati Medical Center

    Makati City, Philippines

  • Medical college of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • North Shore Hospital

    Takapuna, New Zealand

  • Northern Health

    Epping, Australia

  • Palmerston North Hospital

    Palmerston North, New Zealand

  • Pratia MCM

    Krakow, Poland

  • Pratia Onkologia Katowice

    Katowice, Poland

  • Pusan National University Hospital PNUH

    Pusan, South Korea

  • Royal Prince Alfred Hospital

    Sydney, Australia

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Szabolcs-Szatmar-Bereg County Hospitals and University Hospital, Josa Andras University Hospital

    Nyíregyháza, Hungary

  • The Alfred Hospital

    Melbourne, Australia

  • UKC - University Clinical Center Tuzla

    Tuzla, Bosnia and Herzegovina

  • UMC Utrecht

    Utrecht, Netherlands

  • Universitetssjukhuset i Lund

    Lund, Sweden

  • University Centrum Kliniczne

    Gdansk, Poland

  • University Clinic of Hematology

    Skopje, North Macedonia

  • University Clinical Center of the Republic of the Srpska

    Banja Luka, Bosnia and Herzegovina

  • University General Hospital of Patras

    Rio, Greece

  • University Hospital of Salamanca

    Salamanca, Spain

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Navarra

    Pamplona, Spain

  • Vejle Hospital

    Vejle, Denmark

  • Vseobecna fakultni nemocnice

    New Town, Czechia

  • Wroclaw Medical University

    Wroclaw, Poland

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