Study of MK-1045 to Treat Precursor B-cell Acute Lymphoblastic Leukemia in Adults and Children

What this Trial Is About

Researchers are studying a new treatment called MK-1045 for people with precursor B-cell Acute Lymphoblastic Leukemia B-ALL that has returned after treatment or stopped responding to current therapies. This trial includes two parts a dose escalation phase to find the safest and most effective dose, and a Phase II part to evaluate how well MK-1045 works. The study focuses on safety, tolerability, and treatment response in both adults and children aged 2 years and older. In the dose escalation phase, adults receive MK-1045 doses ranging from 600 to 120,000 micrograms once weekly through intravenous infusion in treatment cycles of 4 weeks. Pediatric patients receive weight-based doses from 320 to 60,000 micrograms on the same weekly schedule. Treatment starts with induction cycles, followed by consolidation and maintenance phases, continuing until certain conditions such as disease progression or intolerable toxicity occur. The study is open-label and non-randomized, assessing MK-1045 administered intravenously over multiple treatment cycles. Participants will have their health closely monitored with regular assessments including adverse event tracking, blood tests, and evaluations of leukemia response. Researchers will measure outcomes such as remission rates, drug levels in the blood, immune cell activity, and survival over periods up to two years. The trial includes both adult and pediatric participants and aims to gather detailed safety and effectiveness data throughout treatment and follow-up periods.

A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)