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A clinical trial of MK-1045 in people with B-cell acute lymphoblastic leukemia
EU CTIS ID: 2025-522267-15-00
What this study is testing
1. Part 1: To evaluate the RP2D and RP2D-1 of MK-1045 (target dose) with respect to CR. 2. Part 1: To evaluate the safety and tolerability of the RP2D and RP2D-1 of MK-1045. 3. Part 2: To compare MK-1045 to blinatumomab with respect to CR. 4. To compare MK-1045 to blinatumomab with respect to OS.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥12 years of age.
- 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.
You likely can't join if
- 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.
- Has not adequately recovered from major surgery or have ongoing surgical complications.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Australia
- United States
- New Zealand
- Mexico
- Chile
- Canada
- Israel
- China
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Australia; United States; New Zealand; Mexico; Chile and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.