An Open-label, Multi-center Phase Ib/II Study of MK-1045 (CN201) in Subjects With Precursor B-cell Acute Lymphoblastic Leukemia
Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
West China Second University Hospital, Sichuan University ( Site 0011)
COMPLETED
Chengdu
The Second Affiliated Hospital of Third Military Medical University ( Site 0008)
RECRUITING
Chongqing
Southern Medical University Nanfang Hospital ( Site 0004)
RECRUITING
Guangzhou
The Children's Hospital of Zhejiang University School of Medicine ( Site 0009)
COMPLETED
Hangzhou
The First Hospital of Harbin ( Site 0005)
RECRUITING
Harbin
The Second Hospital of Hebei Medical University ( Site 0003)
RECRUITING
Shijiazhuang
Hematology Hospital of Chinese Academy of Medical Sciences ( Site 0001)
RECRUITING
Tianjin
Tongji Hospital affiliated to Tongji Medical College of HUST ( Site 0006)
RECRUITING
Wuhan
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology ( Site 0010)
RECRUITING
Wuhan
The Affiliated Hospital of Xuzhou Medical University ( Site 0007)
ACTIVE_NOT_RECRUITING
Xuzhou
Henan Cancer Hospital-hematology department ( Site 0002)
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.
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.