Actively Recruiting
A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
Led by MSD R&D (China) Co., Ltd. · Updated on 2026-02-13
203
Participants Needed
11
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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) with more than 5% blasts in bone marrow
- Participants with Ph-negative B-ALL who have either failed to achieve complete remission after initial or salvage treatment, relapsed within 12 months of first remission, experienced second or later relapse, or relapsed after allogeneic HSCT
- Participants with Ph-positive B-ALL who have received two or more tyrosine kinase inhibitors and meet the above refractory/relapse criteria or have the T315I mutation
You will not qualify if you...
- History of Burkitt's leukemia
- Received anti-CD19 therapy within 3 months before study entry
- Received allogeneic HSCT within 12 weeks before study entry
- Received prior chimeric antigen receptor T cell (CAR-T) therapy within 3 months before study entry
- History or presence of clinically relevant central nervous system (CNS) pathology
- History of symptomatic or uncontrolled metastases to CNS or meninges
- History of immunodeficiency, including positive HIV antibody test
- History of serious cardiovascular or cerebrovascular disease
- Has active autoimmune diseases that may relapse
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
The Second Affiliated Hospital of Third Military Medical University ( Site 0008)
Chongqing, Chongqing Municipality, China, 400037
Actively Recruiting
2
Southern Medical University Nanfang Hospital ( Site 0004)
Guangzhou, Guangdong, China, 510515
Actively Recruiting
3
The Second Hospital of Hebei Medical University ( Site 0003)
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
4
The First Hospital of Harbin ( Site 0005)
Harbin, Heilongjiang, China, 150010
Actively Recruiting
5
Henan Cancer Hospital-hematology department ( Site 0002)
Zhengzhou, Henan, China, 450008
Actively Recruiting
6
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology ( Site 0010)
Wuhan, Hubei, China, 430022
Actively Recruiting
7
Tongji Hospital affiliated to Tongji Medical College of HUST ( Site 0006)
Wuhan, Hubei, China, 430030
Actively Recruiting
8
The Affiliated Hospital of Xuzhou Medical University ( Site 0007)
Xuzhou, Jiangsu, China, 221006
Active, Not Recruiting
9
West China Second University Hospital, Sichuan University ( Site 0011)
Chengdu, Sichuan, China, 610000
Completed
10
Hematology Hospital of Chinese Academy of Medical Sciences ( Site 0001)
Tianjin, Tianjin Municipality, China, 301617
Actively Recruiting
11
The Children's Hospital of Zhejiang University School of Medicine ( Site 0009)
Hangzhou, Zhejiang, China, 310003
Completed
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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