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RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07570173

Registry updated: 2026-10-19
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Description

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.

Interventions

  • 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

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

Conditions

B-cell Acute Lymphoblastic Leukemia

Locations

  • Princess Margaret Cancer Center ( Site 0102) — Toronto, Ontario, Canada
  • Rigshospitalet ( Site 0802) — Copenhagen, Capital Region, Denmark
  • Aarhus Universitetshospital. Hæmatologisk afdeling ( Site 0804) — Aarhus Nord, Central Jutland, Denmark
  • Odense Universitetshospital ( Site 0801) — Odense C, Region Syddanmark, Denmark
  • Hopital Saint-Louis ( Site 4100) — Paris, Île-de-France Region, France
  • Evangelismos General Hospital of Athens ( Site 5100) — Athens, Attica, Greece
  • General Hospital of Athens "Laiko" ( Site 5101) — Athens, Attica, Greece
  • General Hospital of Athens "Laiko" ( Site 5104) — Athens, Attica, Greece
  • University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5102) — Chaïdári, Attica, Greece
  • University Hospital of Ioannina ( Site 5103) — Ioannina, Greece
  • Rambam Health Care Campus ( Site 0903) — Haifa, Israel
  • Haddasah Medical Center ( Site 0900) — Jerusalem, Israel
  • Sheba Medical Center ( Site 0902) — Ramat Gan, Israel
  • Sourasky Medical Center. ( Site 0904) — Tel Aviv, Israel
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1002) — Bergamo, Lombardy, Italy
  • Policlinico Universitario Agostino Gemelli ( Site 1003) — Rome, Roma, Italy
  • Tokyo Metropolitan Komagome Hospital ( Site 2106) — Bunkyo, Tokyo, Japan
  • Toranomon Hospital ( Site 2101) — Minato, Tokyo, Japan
  • Radboud UMC ( Site 2003) — Geert Grooteplein-Zuid 8, Gelderland, Netherlands
  • Amsterdam UMC ( Site 2001) — Amsterdam, North Holland, Netherlands
  • Erasmus Medisch Centrum ( Site 2000) — Rotterdam, South Holland, Netherlands
  • Institut Català d'Oncologia (ICO) - Badalona ( Site 3001) — Badalona, Barcelona, Spain
  • Clinica Universidad de Navarra ( Site 3006) — Pamplona, Navarre, Spain
  • Hospital Universitario Central de Asturias ( Site 3008) — Oviedo, Principality of Asturias, Spain
  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 3009) — Madrid, Spain
  • Hospital Universitario de Salamanca ( Site 3002) — Salamanca, Spain
  • Karolinska Universitetssjukhuset ( Site 4002) — Stockholm, Stockholm County, Sweden
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record