Actively Recruiting
Study of MK-1045 to Treat Precursor B-cell Acute Lymphoblastic Leukemia in Adults and Children
Led by MSD R&D (China) Co., Ltd. · Updated on 2026-07-13
203
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participants must be age 18 or older
- Pediatric participants must be at least 2 years old and less than 18 years old
- Diagnosis of precursor B-cell acute lymphoblastic leukemia (B-ALL) with more than 5% blasts in bone marrow
- Ph-negative B-ALL with refractory/relapse criteria including failure to achieve remission after initial or salvage treatment, relapse within 12 months, second or later relapse, or relapse after allogeneic HSCT
- Ph-positive B-ALL with at least 2 tyrosine kinase inhibitors received and meeting refractory/relapse criteria or presence of T315I mutation
You will not qualify if you...
- History of Burkitt's leukemia
- Received anti-CD19 therapy within 3 months prior to study entry
- Received allogeneic HSCT within 12 weeks prior to study entry
- Received prior chimeric antigen receptor T cell (CAR-T) therapy within 3 months prior to study entry
- History or presence of clinically relevant central nervous system pathology or symptomatic metastases
- History of immunodeficiency including HIV positive test
- History of serious cardiovascular and cerebrovascular disease
- Active autoimmune diseases that may relapse
Research Team
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