A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
NCT ID: NCT05579132
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
203 participants
INTERVENTIONAL
2022-11-01
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MK-1045: Dose Escalation Phase- Adult Cohort
Adults in the dose escalation phase will receive a target dose level of MK-1045 from 600 μg to 90000 μg, administered by intravenous (IV) infusion. MK-1045 will be administered once per week, in treatment cycles defined as 4 weeks of MK-1045 treatment.
MK-1045
MK-1045 is administered by IV infusion once a week (QW), 4 weeks per treatment cycle, starting with 2 cycles of induction treatment. After a 2-week treatment-free interval, responders to induction treatment receive 3 cycles of consolidation therapy, and up to 7 cycles of maintenance treatment or until intolerable toxicity, disease progression, withdrawal of informed consent, loss to follow-up, receipt of other antitumor therapy, or death, whichever occurs first. Each 4 week treatment cycle is followed by a 2-week treatment-free interval
MK-1045 : Dose Escalation Phase- Pediatric Cohort
Pediatric participants will receive a target dose level of MK-1045 from 320 μg to 60000 μg, with dosing further based upon weight. MK-1045 will be administered by IV infusion once per week, in treatment cycles defined as 4 weeks of MK-1045 treatment.
MK-1045
MK-1045 is administered by IV infusion once a week (QW), 4 weeks per treatment cycle, starting with 2 cycles of induction treatment. After a 2-week treatment-free interval, responders to induction treatment receive 3 cycles of consolidation therapy, and up to 7 cycles of maintenance treatment or until intolerable toxicity, disease progression, withdrawal of informed consent, loss to follow-up, receipt of other antitumor therapy, or death, whichever occurs first. Each 4 week treatment cycle is followed by a 2-week treatment-free interval
Interventions
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MK-1045
MK-1045 is administered by IV infusion once a week (QW), 4 weeks per treatment cycle, starting with 2 cycles of induction treatment. After a 2-week treatment-free interval, responders to induction treatment receive 3 cycles of consolidation therapy, and up to 7 cycles of maintenance treatment or until intolerable toxicity, disease progression, withdrawal of informed consent, loss to follow-up, receipt of other antitumor therapy, or death, whichever occurs first. Each 4 week treatment cycle is followed by a 2-week treatment-free interval
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
ALL
No
Sponsors
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MSD R&D (China) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jianxiang Wang, Dr.
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Locations
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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
The Children's Hospital of Zhejiang University School of Medicine ( Site 0009)
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Study Coordinator
Role: primary
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-1045-002
Identifier Type: OTHER
Identifier Source: secondary_id
CN201-103
Identifier Type: OTHER
Identifier Source: secondary_id
1045-002
Identifier Type: -
Identifier Source: org_study_id
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