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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
ClinicalTrials.gov ID: NCT07570173
What this study is testing
What is MK-1045?
MK-1045 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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)
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...
- 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...
- 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...
See the full eligibility 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)
- 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...
- 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.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Capital Region, Denmark
- Aarhus Nord, Central Jutland, Denmark
- Odense, Region Syddanmark, Denmark
- Haifa, Israel
- Jerusalem, Israel
- Ramat Gan, Israel
- Tel Aviv, Israel
- Bunkyo, Tokyo, Japan
- Geert Grooteplein-Zuid 8, Gelderland, Netherlands
- Madrid, Spain
- Salamanca, Spain
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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Capital Region, Denmark; Aarhus Nord, Central Jutland, Denmark; Odense, Region Syddanmark, Denmark; Haifa, Israel; Jerusalem, Israel; Ramat Gan, Israel and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.