Recruiting
Phase 2
Phase 3

MK-1045 vs. Blinatumomab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT07570173

Conditions

B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

MK-1045

Blinatumomab

Acetaminophen

Diphenhydramine

Dexamethasone

Study Details

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

Study ID

NCT07570173

Start date

May 18, 2026

Status verified date

Oct, 2026

Completion date

Oct 18, 2033

Anticipated

Primary completion date

Oct 18, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

340 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MK-1045 Dose Regimen A

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.

experimental: MK-1045 Dose Regimen B

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.

active comparator: Blinatumomab

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

Interventions

MK-1045

Intravenous administration

Blinatumomab

Intravenous administration

Acetaminophen

Oral administration as a premedication

Diphenhydramine

Intravenous administration as a premedication

Dexamethasone

Intravenous administration as a premedication

Tocilizumab

Intravenous administration as a rescue medication

Siltuximab

Intravenous administration as a rescue medication

Avtozma

Intravenous administration as a rescue medication

Tyenne

Intravenous administration as a rescue medication

Primary outcome measure

  • 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) ]
  • 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) ]
  • 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) ]
  • Overall Survival (OS) in Study Part 2 [ Time Frame: Up to approximately 7 years ]

Central Contacts and Locations

Central contacts

Toll Free Number

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

Locations

Princess Margaret Cancer Center ( Site 0102)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

416-946-4501

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.