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

NCT07570173 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Diphenhydramine

Intravenous administration as a premedication

DRUG

Dexamethasone

Intravenous administration as a premedication

DRUG

Tocilizumab

Intravenous administration as a rescue medication

DRUG

Siltuximab

Intravenous administration as a rescue medication

DRUG

Avtozma

Intravenous administration as a rescue medication

DRUG

Tyenne

Intravenous administration as a rescue medication

BIOLOGICAL

MK-1045

Intravenous administration

BIOLOGICAL

Blinatumomab

Intravenous administration

DRUG

Acetaminophen

Oral administration as a premedication

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-22
Primary Completion
2029-02-10
Completion
2029-10-02
FDA Drug
Yes

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07570173 on ClinicalTrials.gov