A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)

Summary

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. This trial will compare MK-1045 to a standard immunotherapy called blinatumomab. The goals of this trial are to learn if more people who receive MK-1045 have no cancer cells in their bone marrow compared to people who receive blinatumomab and if people who receive MK-1045 live longer compared to people who receive blinatumomab.

Eligibility

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.

Conditions2

Interventions9

Related trials

• Intravenous Acetaminophen After Cardiac Surgery - Definitive Study — McGill University Health Centre/Research Institute of the McGill University Health Centre
• Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma — Benjamin T Diamond, MD
• NSAID Use After Robotic Partial Nephrectomy — University of Miami
• Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial — Emory University
• Post-Op Pain Control for Prophylactic Intramedullary Nailing. — St. Louis University
• A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma — M.D. Anderson Cancer Center
• A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia — Mats Heyman
• ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL — Institute of Hematology & Blood Diseases Hospital, China

Browse More Trials