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NCT07570173From ClinicalTrials.govRecruiting

A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)

A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)

  • B-cell Acute Lymphoblastic Leukemia

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
340
Started
18 May 2026
Main results due
18 October 2033
Study sites
23
Registry updated
25 September 2026

Can you take part?

  • Aged 12 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

Researchers are looking for new ways to treat people with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) that is CD19 positive using a medicine called MK-1045. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer. This trial will compare MK-1045 to a standard immunotherapy called blinatumomab. The goals of this trial are to learn if more people who receive MK-1045 have no cancer cells in their bone marrow compared to people who receive blinatumomab and if people who receive MK-1045 live longer compared to people who receive blinatumomab.

Study sites(23)

  • Rigshospitalet ( Site 0802)

    Copenhagen, Capital Region, Denmark

    Recruiting

  • Aarhus Universitetshospital. Hæmatologisk afdeling ( Site 0804)

    Aarhus Nord, Central Jutland, Denmark

    Recruiting

  • Odense Universitetshospital ( Site 0801)

    Odense C, Region Syddanmark, Denmark

    Recruiting

  • Evangelismos General Hospital of Athens ( Site 5100)

    Athens, Attica, Greece

    Recruiting

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

    Athens, Attica, Greece

    Recruiting

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

    Athens, Attica, Greece

    Recruiting

  • University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5102)

    Chaïdári, Attica, Greece

    Recruiting

  • University Hospital of Ioannina ( Site 5103)

    Ioannina, Greece

    Recruiting

  • Rambam Health Care Campus ( Site 0903)

    Haifa, Israel

    Recruiting

  • Haddasah Medical Center ( Site 0900)

    Jerusalem, Israel

    Recruiting

  • Sheba Medical Center ( Site 0902)

    Ramat Gan, Israel

    Recruiting

  • Sourasky Medical Center. ( Site 0904)

    Tel Aviv, Israel

    Recruiting

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

    Bergamo, Lombardy, Italy

    Recruiting

  • Policlinico Universitario Agostino Gemelli ( Site 1003)

    Rome, Roma, Italy

    Recruiting

  • Tokyo Metropolitan Komagome Hospital ( Site 2106)

    Bunkyo, Tokyo, Japan

    Recruiting

  • Toranomon Hospital ( Site 2101)

    Minato, Tokyo, Japan

    Recruiting

  • Radboud UMC ( Site 2003)

    Geert Grooteplein-Zuid 8, Gelderland, Netherlands

    Recruiting

  • Amsterdam UMC ( Site 2001)

    Amsterdam, North Holland, Netherlands

    Recruiting

  • Erasmus Medisch Centrum ( Site 2000)

    Rotterdam, South Holland, Netherlands

    Recruiting

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

    Badalona, Barcelona, Spain

    Recruiting

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 3009)

    Madrid, Spain

    Recruiting

  • Hospital Universitario de Salamanca ( Site 3002)

    Salamanca, Spain

    Recruiting

  • Karolinska Universitetssjukhuset ( Site 4002)

    Stockholm, Stockholm County, Sweden

    Recruiting

Showing 23 of 23 sites. 23 of the 23 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07570173. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) | Trialion