drugset / Trial / NCT07570173

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

NCT07570173

Phase 2/3 Recruiting 340 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2026-05-18
Primary completion
2033-10-18
Completion
2033-10-18

Drugs

EvaluationDrugModalityDoseRoute
Comparator Blinatumomab Monoclonal antibody Intravenous
Subject MK-1045 Other / unclassified Intravenous
Background Acetaminophen Small molecule Oral
Background Avtozma Unknown Intravenous
Background Dexamethasone Small molecule Intravenous
Background Diphenhydramine Unknown Intravenous
Background Siltuximab Monoclonal antibody Intravenous
Background Tocilizumab Monoclonal antibody Intravenous