Actively Recruiting
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-12
340
Participants Needed
1
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) with 5% or more lymphoblasts in bone marrow
- Disease positive for CD19 confirmed by testing at enrollment
- Philadelphia-negative disease confirmed by testing at enrollment
- Recovery to Grade 1 or baseline from adverse events of previous cancer treatments
- Well-controlled HIV infection on antiretroviral therapy (ART)
You will not qualify if you...
- Diagnosis of Burkitt's leukemia
- Presence or history of serious central nervous system diseases such as epilepsy, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- Active acute graft versus host disease (GvHD) Grade 2 to 4 or chronic GvHD requiring systemic treatment
- History of serious cardiovascular or cerebrovascular diseases
- HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Prior blinatumomab treatment within 12 weeks for Part 1 or 24 weeks for Part 2 before first study dose
- Diagnosis of immunodeficiency or use of high-dose systemic steroids or immunosuppressive therapy within 7 days before first study dose
- Other active malignancies progressing or treated within past 2 years
- Isolated extramedullary disease
- Active autoimmune disease unrelated to ALL requiring systemic treatment in past 2 years or autoimmune disease with possible CNS involvement
- Active infection needing systemic therapy
- Incomplete recovery from major surgery or ongoing surgical complications
AI-Screening
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Trial Site Locations
Total: 1 location
1
Haddasah Medical Center ( Site 0900)
Jerusalem, Israel, 9112001
Actively Recruiting
Research Team
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Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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