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New hope for tough leukemia: MK-1045 takes on standard therapy

NCT ID NCT07570173

Disease control Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 16 times

Summary

This study compares a new immunotherapy, MK-1045, to the standard drug blinatumomab in people whose B-cell acute lymphoblastic leukemia has returned or stopped responding to treatment. About 340 adults with CD19-positive leukemia will receive one of the two treatments. The goal is to see if MK-1045 leads to more complete remissions and longer survival.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 340 people

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

Started

May 2026

Expected to finish

Oct 2033

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

12 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.

Inclusion Criteria: * Has a confirmed diagnosis of relapsed/refractory (R/R) B-precursor acute lymphoblastic leukemia (ALL) with 5% or more lymphoblasts in the bone marrow * Has CD19+ disease, confirmed by local flow cytometry and/or immunohistochemistry testing at the time of enrollment * Has Philadelphia-negative disease, confirmed by testing, at the time of enrollment * Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: * Has Burkitt's leukemia * History or presence of clinically relevant central nervous system (CNS) diseases such as epilepsy, hemorrhagic/ischemic stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis * Has active acute graft versus host disease (GvHD) or chronic GvHD. NOTE: Participants who have received CNI for GvHD within 4 weeks before the first dose of study intervention are also excluded * History of serious cardiovascular and cerebrovascular diseases. * HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Received prior treatment with blinatumomab within 12 weeks for Part 1 and 24 weeks for Part 2 before the first dose of study intervention (individuals known to be refractory or intolerant to blinatumomab are to be excluded). Refractory to blinatumomab is defined as failure to achieve a response after at least 2 cycles of previous blinatumomab treatment * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Known additional malignancy that is progressing or has required active treatment within the past 2 years * Isolated extramedullary disease (EMD) * Active autoimmune disease unrelated to ALL that has required systemic treatment in the past 2 years or history of autoimmune disease with potential CNS involvement * Active infection requiring systemic therapy * Has not adequately recovered from major surgery or have ongoing surgical complications

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia Burkitt lymphoma

As listed by the trial registrant

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

B-cell acute lymphoblastic leukemia

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    22 sites in 8 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aarhus Universitetshospital. Hæmatologisk afdeling ( Site 0804)

    RECRUITING

    Aarhus Nord, Central Jutland, 8200, Denmark

  • Amsterdam UMC ( Site 2001)

    RECRUITING

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1002)

    RECRUITING

    Bergamo, Lombardy, 24127, Italy

  • Erasmus Medisch Centrum ( Site 2000)

    RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Evangelismos General Hospital of Athens ( Site 5100)

    RECRUITING

    Athens, Attica, 106 76, Greece

  • General Hospital of Athens "Laiko" ( Site 5101)

    RECRUITING

    Athens, Attica, 115 27, Greece

  • General Hospital of Athens "Laiko" ( Site 5104)

    RECRUITING

    Athens, Attica, 115 27, Greece

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 3009)

    RECRUITING

    Madrid, 28233, Spain

  • Haddasah Medical Center ( Site 0900)

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hospital Universitario de Salamanca ( Site 3002)

    RECRUITING

    Salamanca, 37007, Spain

  • Institut Català d'Oncologia (ICO) - Badalona ( Site 3001)

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • Karolinska Universitetssjukhuset ( Site 4002)

    RECRUITING

    Stockholm, Stockholm County, 171 76, Sweden

  • Odense Universitetshospital ( Site 0801)

    RECRUITING

    Odense C, Region Syddanmark, 5000, Denmark

  • Policlinico Universitario Agostino Gemelli ( Site 1003)

    RECRUITING

    Rome, Roma, 00168, Italy

  • Radboud UMC ( Site 2003)

    RECRUITING

    Geert Grooteplein-Zuid 8, Gelderland, 6500 HB, Netherlands

  • Rambam Health Care Campus ( Site 0903)

    RECRUITING

    Haifa, 3109601, Israel

  • Rigshospitalet ( Site 0802)

    RECRUITING

    Copenhagen, Capital Region, 2100, Denmark

  • Sheba Medical Center ( Site 0902)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Sourasky Medical Center. ( Site 0904)

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Tokyo Metropolitan Komagome Hospital ( Site 2106)

    RECRUITING

    Bunkyo, Tokyo, 113-8677, Japan

  • Toranomon Hospital ( Site 2101)

    RECRUITING

    Minato, Tokyo, 105-8470, Japan

  • University Hospital of Ioannina ( Site 5103)

    RECRUITING

    Ioannina, 455 00, Greece

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