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NCT Number: NCT07570173

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

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.

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Key information

Conditions

B-cell Acute Lymphoblastic Leukemia Burkitt Lymphoma DNA Virus Infections Epstein-Barr Virus Infections Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Tumor Virus Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Rigshospitalet ( Site 0802), Copenhagen, Capital Region, Denmark

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About this study

This study has 2 parts: Part 1 is a dose optimization phase of MK-1045. Part 2 is a randomized phase comparing the efficacy and safety of MK-1045 versus blinatumomab and will use the recommended dose of MK-1045 determined in Part 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-1045

Biological

Intravenous administration

Blinatumomab

Biological

Intravenous administration

Acetaminophen

Drug

Oral administration as a premedication

diphenhydramine

Drug

Intravenous administration as a premedication

Dexamethasone

Drug

Intravenous administration as a premedication

Tocilizumab

Drug

Intravenous administration as a rescue medication

Siltuximab

Drug

Intravenous administration as a rescue medication

Avtozma

Drug

Intravenous administration as a rescue medication

Tyenne

Drug

Intravenous administration as a rescue medication

Primary outcomes

  1. Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2

    Time frame: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

    CR is defined as:

    • No circulating lymphoblasts
    • Extramedullary disease negative
    • Trilineage hematopoiesis (TLH) and <5% leukemic blasts
    • Absolute neutrophil count (ANC) ≥1000/μL
    • Platelets ≥100,000/μL
    • No platelet transfusions in the last 7 days
    • No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

  2. Percentage of Participants Who Experience an Adverse Event (AE) in Study Part 1

    Time frame: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with at least 1 AE will be presented.

  3. Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 1

    Time frame: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study intervention due to an AE will be presented.

  4. Overall Survival (OS) in Study Part 2

    Time frame: Up to approximately 7 years

    OS is the time from randomization to death due to any cause.

Secondary outcomes

  1. Overall survival (OS) in Study Part 1

    Time frame: Up to approximately 7 years

    OS is the time from randomization to death due to any cause.

  2. Percentage of Participants that achieve Minimal Residual Disease (MRD) in Study Part 1 and Part 2

    Time frame: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

    MRD is defined as no detectable leukemia cells below a threshold of at least 10^-4.

  3. Percentage of Participants that achieve CR/CR with partial hematologic recovery (CRh)/CR with incomplete count recovery (CRi) in Study Part 1 and Part 2

    Time frame: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

    For participants who demonstrate CR or CRh or CRi, duration of remission is defined as the time from the first documented evidence of CR or CRh or CRi (whichever is earlier) until disease progression, relapse, or death due to any cause, whichever occurs first.

    CR is defined as:

    • No circulating lymphoblasts
    • Extramedullary disease negative
    • Trilineage hematopoiesis (TLH) and <5% leukemic blasts
    • Absolute neutrophil count (ANC) ≥1000/μL
    • Platelets ≥100,000/μL
    • No platelet transfusions in the last 7 days
    • No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

    CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).

    CRi is the same as CR but without recovery of platelet count or without recovery of ANC (platelets <100,000/μL and ANC ≥1000/μL or platelets ≥100,000/μL and ANC <1000/μL.

  4. Percentage of Participants with CR or CRh in Study Part 2

    Time frame: 3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

    The percentage of participants who meet either CR or CRh requirements will be presented.

    CR is defined as:

    • No circulating lymphoblasts
    • Extramedullary disease negative
    • Trilineage hematopoiesis (TLH) and <5% leukemic blasts
    • Absolute neutrophil count (ANC) ≥1000/μL
    • Platelets ≥100,000/μL
    • No platelet transfusions in the last 7 days
    • No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

    CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).

  5. Duration of CR (DOR-CR) in Study Part 2

    Time frame: Up to approximately 7 years

    For participants who demonstrate CR, duration of remission is defined as the time from the first documented evidence of CR until disease progression, relapse, or death due to any cause, whichever occurs first.

    CR is defined as:

    • No circulating lymphoblasts
    • Extramedullary disease negative
    • Trilineage hematopoiesis (TLH) and <5% leukemic blasts
    • Absolute neutrophil count (ANC) ≥1000/μL
    • Platelets ≥100,000/μL
    • No platelet transfusions in the last 7 days
    • No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

  6. Duration of CR/CRh (DOR-CR/CRh) in Study Part 2

    Time frame: Up to approximately 7 years

    For participants who demonstrate CR or CRh, duration of remission is defined as the time from the first documented evidence of CR or CRh (whichever is earlier) until disease progression, relapse, or death due to any cause, whichever occurs first.

    CR is defined as:

    • No circulating lymphoblasts
    • Extramedullary disease negative
    • Trilineage hematopoiesis (TLH) and <5% leukemic blasts
    • Absolute neutrophil count (ANC) ≥1000/μL
    • Platelets ≥100,000/μL
    • No platelet transfusions in the last 7 days
    • No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

    CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).

  7. Duration of CR/CRh/CRi (DOR-CR/CRh/CRi) in Study Part 2

    Time frame: Up to approximately 7 years

    For participants who demonstrate CR or CRh or CRi, duration of remission is defined as the time from the first documented evidence of CR or CRh or CRi (whichever is earlier) until disease progression, relapse, or death due to any cause, whichever occurs first.

    CR is defined as:

    • No circulating lymphoblasts
    • Extramedullary disease negative
    • Trilineage hematopoiesis (TLH) and <5% leukemic blasts
    • Absolute neutrophil count (ANC) ≥1000/μL
    • Platelets ≥100,000/μL
    • No platelet transfusions in the last 7 days
    • No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

    CRh is the same as CR but with less stringent requirements for platelet count (≥50,000/μL) and ANC (≥500/μL).

    CRi is the same as CR but without recovery of platelet count or without recovery of ANC (platelets <100,000/μL and ANC ≥1000/μL or platelets ≥100,000/μL and ANC <1000/μL.

  8. Event Free Survival (EFS) in Study Part 2

    Time frame: Up to approximately 7 years

    The time from randomization to the first documented disease progression, relapse, or death due to any cause, whichever occurs first.

  9. Percentage of participants that proceed to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in Study Part 2

    Time frame: Up to approximately 7 years

    The use of allo-HSCT treatment after randomization.

  10. Percentage of Participants Who Experience an AE in Study Part 2

    Time frame: Up to approximately 7 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants with at least 1 AE will be presented.

  11. Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 2

    Time frame: Up to approximately 7 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study intervention due to an AE will be presented.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
May 6, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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