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RECRUITING
NCT05579132
PHASE1/PHASE2

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

Sponsor: 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.

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

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

203

Start Date

2022-11-01

Completion Date

2028-06-30

Last Updated

2026-02-13

Healthy Volunteers

No

Interventions

DRUG

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.

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

The Children's Hospital of Zhejiang University School of Medicine ( Site 0009)

Hangzhou, Zhejiang, China