Actively Recruiting
An Open-label, Multi-center Study of MK-1045 in People With Precursor B-cell Acute Lymphoblastic Leukemia
Led by MSD R&D (China) Co., Ltd. · Updated on 2026-06-01
203
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment called MK-1045 for people with precursor B-cell Acute Lymphoblastic Leukemia (B-ALL), a type of blood cancer that has returned after treatment or stopped responding to current therapies. The study has two parts: the first part focuses on finding the safe and best dose levels of MK-1045, while the second part aims to learn how well MK-1045 works to treat this condition. Adults in the dose escalation phase will receive weekly intravenous infusions of MK-1045 at doses ranging from 600 to 120,000 micrograms, given in treatment cycles of 4 weeks. Pediatric participants receive weight-based doses from 320 to 60,000 micrograms with the same weekly IV infusion schedule. Treatment cycles include 4 weeks of dosing followed by a 2-week break, with induction, consolidation, and maintenance phases depending on response and tolerance. Participants will be closely monitored throughout the study, with assessments for side effects, blood tests, and evaluations of cancer remission rates. Researchers will measure various outcomes such as adverse events, dose tolerability, complete remission rates, immune responses, and survival over periods ranging from weeks to up to 24 months. The study aims to understand both the safety and potential effectiveness of MK-1045 in treating precursor B-cell ALL.
CONDITIONS
Brief 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 by morphological assessment
- Ph-negative B-ALL with refractory or relapse criteria including failure to achieve complete remission after initial induction or salvage treatment, relapse within 12 months of first remission, second or later relapse, or relapse after allogeneic hematopoietic stem cell transplant
- Ph-positive B-ALL with at least two tyrosine kinase inhibitors received and meeting refractory/relapse criteria or having 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 hematopoietic stem cell transplant within 12 weeks before study entry
- Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy within 3 months before study entry
- History or presence of clinically relevant central nervous system pathology
- History of symptomatic metastases or uncontrolled metastases to the central nervous system or meninges
- History of immunodeficiency including HIV positive test
- History of serious cardiovascular or cerebrovascular disease
- Active autoimmune diseases that may relapse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months
Participants receive MK-1045 by intravenous infusion once a week in 4-week treatment cycles. The treatment begins with 2 cycles of induction therapy, followed by a 2-week treatment-free interval. Responders then receive 3 cycles of consolidation therapy, and up to 7 cycles of maintenance therapy or until certain conditions occur such as intolerable toxicity or disease progression. Each treatment cycle is followed by a 2-week break.
Weekly visits for each 4-week treatment cycle with 2-week breaks between cycles
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, 221002
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
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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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