Tests MK-1045 in people with returned or non-responding blood cancer
Tests MK-1045 in people aged 2 years and older with relapsed or refractory B-cell leukemia.
Plain-language title generated from the registry record
Registry title: A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
Key facts
- Where
- Chengdu, Chongqing, Guangzhou, Hangzhou, Harbin, Shijiazhuang, Tianjin, Wuhan, Xuzhou, and Zhengzhou, ChinaSee the 11 sites
- Phase
- Phase 1/2
Where in China
- West China Second University Hospital, Sichuan University (Site 0011)Chengdu, ChinaNo longer taking part
- The Second Affiliated Hospital of Third Military Medical University (Site 0008)Chongqing, ChinaTaking people
- Southern Medical University Nanfang Hospital (Site 0004)Guangzhou, ChinaTaking people
- The Children's Hospital of Zhejiang University School of Medicine (Site 0009)Hangzhou, ChinaNo longer taking part
- The First Hospital of Harbin (Site 0005)Harbin, ChinaTaking people
- The Second Hospital of Hebei Medical University (Site 0003)Shijiazhuang, ChinaTaking people
- Hematology Hospital of Chinese Academy of Medical Sciences (Site 0001)Tianjin, ChinaTaking people
- Tongji Hospital affiliated to Tongji Medical College of HUST (Site 0006)Wuhan, ChinaTaking people
- Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology (Site 0010)Wuhan, ChinaTaking people
- The Affiliated Hospital of Xuzhou Medical University (Site 0007)Xuzhou, ChinaNo longer taking part
- Henan Cancer Hospital-hematology department (Site 0002)Zhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- MSD R&D (China) Co., Ltd.
- Trial code
- NCT05579132
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
An Open-label, Multi-center Phase Ib/II Study of MK-1045 (CN201) in Subjects With Precursor B-cell Acute Lymphoblastic Leukemia
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.
The main inclusion criteria include but are not limited to:; 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; The main exclusion criteria include but are not limited to:; 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; Has CNS infiltration. Participants who had previous CNS infiltration, but it was controlled with intrathecal therapy are permitted to enroll; 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.