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A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002) | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)

An Open-label, Multi-center Phase Ib/II Study of MK-1045 (CN201) in Subjects With Precursor B-cell Acute Lymphoblastic Leukemia

NCT05579132•MSD R&D (China) Co., Ltd.

View on ClinicalTrials.gov

Summary

Researchers are looking for new ways to treat people with a type of blood cancer called precursor B-cell Acute Lymphoblastic Leukemia (B-ALL) that is relapsed- the cancer has come back after treatment, or refractory - the current treatment has stopped working to slow or stop cancer growth. This study will have two parts. In the first part (dose escalation phase) the goal is to learn about the safety of a study treatment, MK-1045, and to find the best dose level of MK-1045 that is tolerated and may work to treat B-ALL. In the second part (Phase II) researchers want to learn how well MK-1045 works to treat B-ALL.

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult participants must be age 18 or older
•Pediatric participants must be at least 2 years old and less than 18 years old.
•Diagnosis of precursor B-cell acute lymphoblastic leukemia (B-ALL) and have more than 5% blasts in the bone marrow by morphological assessment
•Participants with Ph-negative B-ALL with any of the following refractory/relapse criteria:
•* Failure to achieve complete remission after initial induction therapy;
•* Failure to achieve complete remission after salvage treatment;
•* Relapse with first remission duration ≤12 months
•* Second or later relapse
•* Relapse after allogeneic HSCT
•Participants with Ph-positive B-ALL who have received 2 (or more) tyrosine kinase inhibitors (TKIs) and meet the refractory/relapse criteria above or, those with the T315I mutation

Exclusion Criteria

•History of Burkitt's leukemia.
•Received anti-CD19 therapy within 3 months prior to entering the study
•Received allogeneic HSCT within 12 weeks prior to entering the study
•Received prior treatment with chimeric antigen receptor T cell (CAR-T) within 3 months prior to entering the study
•History or presence of clinically relevant central nervous system (CNS) pathology
•History of clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the CNS or meninges
•History of immunodeficiency, including history of any positive test result for human immunodeficiency virus (HIV) antibody.
•History of serious cardiovascular and cerebrovascular disease
•Has active autoimmune diseases that may relapse

Locations (11)

The Second Affiliated Hospital of Third Military Medical University ( Site 0008)

Chongqing, Chongqing Municipality, China

Southern Medical University Nanfang Hospital ( Site 0004)

Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University ( Site 0003)

Shijiazhuang, Hebei, China

The First Hospital of Harbin ( Site 0005)

Harbin, Heilongjiang, China

Henan Cancer Hospital-hematology department ( Site 0002)

Zhengzhou, Henan, China

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology ( Site 0010)

Wuhan, Hubei, China

Tongji Hospital affiliated to Tongji Medical College of HUST ( Site 0006)

Wuhan, Hubei, China

The Affiliated Hospital of Xuzhou Medical University ( Site 0007)

Xuzhou, Jiangsu, China

West China Second University Hospital, Sichuan University ( Site 0011)

Chengdu, Sichuan, China

Hematology Hospital of Chinese Academy of Medical Sciences ( Site 0001)

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

November 1, 2022

Primary Completion Date

June 30, 2028

Completion Date

June 30, 2028

Last Updated

February 13, 2026

Enrollment

203

ESTIMATED participants

Conditions

Acute Lymphoblastic Leukemia

Interventions

MK-1045

DRUG

Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)

Inclusion Criteria

Exclusion Criteria

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