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

NCT07570173 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: 1045-005MK-1045-0052025-522267-15-00U1111-1322-4387
• Study Type: interventional
• Target: 340
• Locations: 6 countries
• Sites: 12

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 7 years

Secondary Outcomes (11)

• Overall survival (OS) in Study Part 1

  Up to approximately 7 years

• 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 7 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

Tocilizumab 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

Diphenhydramine DRUG

Intravenous administration as a premedication

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

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) 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (12)

Rigshospitalet ( Site 0802)

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Aarhus Universitetshospital. Hæmatologisk afdeling ( Site 0804)

Aarhus Nord, Central Jutland, 8200, Denmark

RECRUITING

Odense Universitetshospital ( Site 0801)

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Rambam Health Care Campus ( Site 0903)

Haifa, 3109601, Israel

RECRUITING

Haddasah Medical Center ( Site 0900)

Jerusalem, 9112001, Israel

RECRUITING

Sheba Medical Center ( Site 0902)

Ramat Gan, 5265601, Israel

RECRUITING

Sourasky Medical Center. ( Site 0904)

Tel Aviv, 6423906, Israel

RECRUITING

Policlinico Universitario Agostino Gemelli ( Site 1003)

Rome, Roma, 00168, Italy

RECRUITING

Tokyo Metropolitan Komagome Hospital ( Site 2106)

Bunkyo, Tokyo, 113-8677, Japan

RECRUITING

Radboud UMC ( Site 2003)

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

RECRUITING

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 3009)

Madrid, 28233, Spain

RECRUITING

Hospital Universitario de Salamanca ( Site 3002)

Salamanca, 37007, Spain

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

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

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

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: May 18, 2026
• Primary Completion (Estimated): October 18, 2033
• Study Completion (Estimated): October 18, 2033
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (2); IT (1); IL (4); DK (3); JP (1); NL (1)