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

NCT07570173 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: 1045-005MK-1045-0052025-522267-15-00U1111-1322-4387
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (4)

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

  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

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

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

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

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

  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.

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

• Overall Survival (OS) in Study Part 2

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

  Up to approximately 8 years

Secondary Outcomes (11)

• Overall survival (OS) in Study Part 1

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

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

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

• 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

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

• Percentage of Participants with CR or CRh in Study Part 2

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

• Duration of CR (DOR-CR) in Study Part 2

  Up to approximately 8 years

Study Arms (3)

MK-1045 Dose Regimen A

EXPERIMENTAL

Participants will receive a lower MK-1045 dose once weekly for up to 13 cycles (two 28-day and eleven 42-day cycles). Participants will have the option to change treatment at the end of Part 1.

Biological: MK-1045; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Dexamethasone; Drug: Tocilizumab; Drug: Siltuximab; Drug: Avtozma; Drug: Tyenne

MK-1045 Dose Regimen B

EXPERIMENTAL

Participants will receive a larger MK-1045 dose once weekly for up to 13 cycles (two 28-day and eleven 42-day cycles). Participants will have the option to change treatment at the end of Part 1.

Biological: MK-1045; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Dexamethasone; Drug: Tocilizumab; Drug: Siltuximab; Drug: Avtozma; Drug: Tyenne

Blinatumomab

ACTIVE COMPARATOR

Participants will receive blinatumomab on days 1, 8, 15, and 22 of each 42-day cycle

Biological: Blinatumomab; Drug: Dexamethasone; Drug: Tocilizumab; Drug: Siltuximab; Drug: Avtozma; Drug: Tyenne

Interventions

MK-1045 BIOLOGICAL

Intravenous administration

MK-1045 Dose Regimen A; MK-1045 Dose Regimen B

Blinatumomab BIOLOGICAL

Intravenous administration

Blinatumomab

Acetaminophen DRUG

Oral administration as a premedication

MK-1045 Dose Regimen A; MK-1045 Dose Regimen B

Diphenhydramine DRUG

Intravenous administration as a premedication

MK-1045 Dose Regimen A; MK-1045 Dose Regimen B

Tocilizumab DRUG

Intravenous administration as a rescue medication

Blinatumomab; MK-1045 Dose Regimen A; MK-1045 Dose Regimen B

Siltuximab DRUG

Intravenous administration as a rescue medication

Blinatumomab; MK-1045 Dose Regimen A; MK-1045 Dose Regimen B

Avtozma DRUG

Intravenous administration as a rescue medication

Blinatumomab; MK-1045 Dose Regimen A; MK-1045 Dose Regimen B

Tyenne DRUG

Intravenous administration as a rescue medication

Blinatumomab; MK-1045 Dose Regimen A; MK-1045 Dose Regimen B

Dexamethasone DRUG

Intravenous administration as a premedication

Blinatumomab; MK-1045 Dose Regimen A; MK-1045 Dose Regimen B

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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), Grade 2 to 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment.
• 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).
• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

blinatumomab; Acetaminophen; Diphenhydramine; Dexamethasone; tocilizumab; siltuximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethylamines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Review of all disease response assessments in the Phase 3 component will be performed by an independent Clinical Adjudication Committee. Reviewers will be blinded to treatment allocation and investigator assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): May 8, 2026
• Primary Completion (Estimated): February 10, 2029
• Study Completion (Estimated): October 2, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share