MK-1045 versus blinatumomab for relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia
A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
This trial will test whether MK-1045 helps people with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia more than the standard immunotherapy blinatumomab.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | blinatumomab, prednisone, immunotherapy |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT07570173 on ClinicalTrials.gov |
What this trial studies
The trial tests MK-1045, a CD19-directed immunotherapy, in people with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). It has two parts: Part 1 determines the recommended dose of MK-1045 and Part 2 randomly assigns participants to receive either MK-1045 or blinatumomab using that dose. The main outcomes include clearance of leukemic cells from the bone marrow and overall survival, with safety closely monitored. The study enrolls patients with CD19-positive, Philadelphia-negative disease who meet recovery and other eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are people with relapsed or refractory B-precursor ALL with at least 5% bone marrow blasts who have CD19-positive, Philadelphia-negative disease and have recovered from prior therapy-related side effects (and HIV patients must have well-controlled infection on ART).
Not a fit: Patients with Burkitt's leukemia, active clinically relevant central nervous system disease, active Grade 2–4 graft-versus-host disease, or CD19-negative disease are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, MK-1045 could produce higher rates of bone marrow remission and potentially longer survival than blinatumomab for people with CD19-positive R/R B-ALL.
How similar studies have performed: Other CD19-directed therapies such as blinatumomab and anti-CD19 CAR-T cells have produced remissions in R/R B-ALL, but MK-1045 is a newer agent being tested directly against blinatumomab in randomized Phase 2/3 comparison.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART). Exclusion Criteria: * 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), Grade 2 to 4 according to the Glucksberg criteria or active chronic GvHD requiring systemic treatment. * History of serious cardiovascular and cerebrovascular diseases. * HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Received prior treatment with blinatumomab within 12 weeks for Part 1 and 24 weeks for Part 2 before the first dose of study intervention (individuals known to be refractory or intolerant to blinatumomab are to be excluded). * Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention. * Known additional malignancy that is progressing or has required active treatment within the past 2 years. * Isolated extramedullary disease (EMD). * Active autoimmune disease unrelated to ALL that has required systemic treatment in the past 2 years or history of autoimmune disease with potential CNS involvement. * Active infection requiring systemic therapy. * Has not adequately recovered from major surgery or have ongoing surgical complications.
Where this trial is running
Jerusalem
- Haddasah Medical Center ( Site 0900) — Jerusalem, Israel (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.