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Study of MK-1045 versus blinatumomab with tocilizumab in patients with relapsed or refractory B-cell acute lymphoblastic leukemia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people with relapsed or refractory CD19+ B-cell Acute Lymphoblastic Leukemia, a type of blood cancer that has returned or does not respond to standard treatments. The investigational drug being tested is called MK-1045, an intravenous medication identified by its code name, and it will be compared with an existing therapy named blinatumomab. Both drugs are given through a vein, and the trial also includes the use of tocilizumab as background medication to help manage certain side effects.

The purpose of the trial is to determine whether MK-1045 can achieve a higher rate of complete remission (no detectable cancer) and improve overall survival (how long participants live) compared with blinatumomab. Participants will receive a series of treatment cycles lasting several weeks, during which doctors will monitor for adverse events (side effects) and check for minimal residual disease negativity (absence of tiny amounts of cancer cells). Some participants may later undergo allogeneic hematopoietic stem cell transplantation, a procedure that replaces diseased blood‑forming cells with healthy ones from a donor, if deemed appropriate by their physicians.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and randomization
After signing the consent form, you are assigned a study number and placed into one of two groups: the mk-1045 group or the blinatumomab group. the assignment is done by a computer program and you do not choose the group.
Step 2
Administration of study medication
If you are in the mk-1045 group, the drug is given by intravenous infusion. the product is described as a solution for infusion with a dose listed as 0 % (v/v) (percent volume/volume).
If you are in the blinatumomab group, the drug is given by intravenous infusion at a dose of 28 µg (microgram) per administration.
Step 3
Monitoring during infusion
While the infusion is running, clinical staff check your vital signs, blood counts, and other laboratory values at regular intervals.
Any signs of an adverse event (for example, fever, low blood pressure, or allergic reaction) are recorded and reported.
Step 4
Assessment of treatment response
After each treatment cycle, doctors evaluate whether a complete remission (cr) has been achieved. the evaluation includes bone‑marrow testing and other standard examinations.
The primary focus is on the first three cycles; response data from these cycles determine the primary outcome of the study.
Step 5
Evaluation of safety and tolerability
Throughout the study, all adverse events are recorded, and the number of participants who discontinue the medication because of an adverse event is tracked.
Laboratory tests and physical examinations are performed regularly to assess tolerability.
Step 6
Continuation or discontinuation of therapy
Based on the response assessment and safety evaluation, you may continue receiving the assigned medication for additional cycles or stop treatment if the medication is not effective or if side effects are unacceptable.
Step 7
Follow‑up for overall survival
After the treatment period ends, you are followed for overall survival, which measures the length of time you remain alive after starting the study medication.
Follow‑up visits may include clinic assessments and collection of survival data.

Who can join the trial?

5 criteria

Be at least 12 years old.
Have a confirmed diagnosis of relapsed/refractory B‑precursor acute lymphoblastic leukemia (ALL) – meaning the leukemia has come back or did not respond to prior treatment – and have at least 5% leukemia cells (lymphoblasts) in the bone marrow, the spongy tissue inside the bones where blood cells are made.
Show CD19‑positive disease, which means the cancer cells have a protein called CD19 on their surface; this must be proven by a lab test called flow cytometry or immunohistochemistry that looks for that protein.
Have Philadelphia‑negative disease, meaning the cancer cells do not have a specific genetic change called the Philadelphia chromosome; this is checked with a genetic test.
Any side effects (adverse events) from earlier cancer treatments must have improved to a mild level (Grade 1 or lower) or returned to the original condition before joining the study.

Who cannot join the trial?

5 criteria

Having Burkitt’s leukemia, a fast‑growing type of blood cancer.
Having or a past history of serious central nervous system (CNS) diseases, such as epilepsy (a condition that causes seizures), stroke caused by bleeding or blockage in the brain, severe brain injury, dementia (significant memory loss), Parkinson’s disease (a movement disorder), cerebellar disease (affects balance and coordination), organic brain syndrome (overall brain dysfunction), or psychosis (loss of contact with reality).
Having active graft‑versus‑host disease (GvHD) – either the sudden (acute) form or the long‑lasting (chronic) form – or having taken immune‑suppressing medicines (CNI) for GvHD within 4 weeks before the first study dose.
Having a past or current serious heart (cardiovascular) or brain‑blood‑vessel (cerebrovascular) disease.
Not having fully recovered from a major surgery or still having complications from that surgery.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliera Ordine Mauriziano Di Torino
Turin, Italy
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Blinatumomab
is an intravenous medication used in this study as the standard treatment to which the new drug is compared. It helps the body’s immune system find and kill leukemia cells that carry a marker called CD19.
Tocilizumab
is an intravenous drug given as background therapy in the trial. It is commonly used to control inflammation and may be used to treat side‑effects such as cytokine release syndrome that can occur during leukemia treatment.
MK-1045
is the experimental therapy being tested. It is given by IV infusion and is designed to target CD19‑positive B‑cell acute lymphoblastic leukemia, with the goal of achieving complete remission and improving overall survival compared with the standard treatment.

What is already known about the treatment

Blinatumomab
This medication is given by intravenous infusion, usually as a continuous drip. It is an approved drug used worldwide for treating relapsed or refractory B‑cell acute lymphoblastic leukemia. It works by linking a protein on T‑cells (CD3) to a protein on leukemia cells (CD19), directing the immune system to kill the cancer cells. It is classified as a bispecific T‑cell engager immunotherapy.
Tocilizumab
This drug is administered by intravenous infusion, often given as a short injection into a vein. It is an approved treatment for conditions such as rheumatoid arthritis and cytokine release syndrome, and it is also used off‑label for severe inflammation. It blocks the activity of interleukin‑6 by binding to its receptor, reducing inflammatory signals in the body. It belongs to the class of IL‑6 receptor antagonist monoclonal antibodies.
MK-1045
This experimental agent is supplied as a solution for infusion and is given by intravenous administration in a clinical trial setting. It is not yet approved and is being studied for its safety and effectiveness in B‑cell acute lymphoblastic leukemia. It is designed to recognize the CD19 marker on leukemia cells and activate immune cells to attack the tumor, similar to other targeted immunotherapies. It is classified as an investigational bispecific antibody or immune‑engaging therapy.

Investigated diseases

Relapsed/refractory B-cell acute lymphoblastic leukemia - It is a type of blood cancer that starts from immature B‑cell precursors in the bone marrow. After initial treatment, the disease can return (relapse) or fail to respond (refractory). When it returns, abnormal cells increase in the marrow and spread to the blood. The condition may also involve the lymph nodes, spleen, or other organs. Over time, the number of healthy blood cells drops, leading to symptoms such as fatigue, bruising, or infections.