Acute Lymphoblastic LeukemiaPhase 1/2NCT05579132
A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)
A Phase 1/2 study testing MK-1045 in people with Acute Lymphoblastic Leukemia, run by MSD R&D (China) Co., Ltd. at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- MK-1045
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 11 sitesChina
- Study dates
- 1 Nov 2022to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 8 recruiting
- Completed
West China Second University Hospital, Sichuan University ( Site 0011)
Chengdu, Sichuan, 610000
- Recruiting
The Second Affiliated Hospital of Third Military Medical University ( Site 0008)
Chongqing, Chongqing Municipality, 400037
Study Coordinator, 023-68755313
- Recruiting
Southern Medical University Nanfang Hospital ( Site 0004)
Guangzhou, Guangdong, 510515
Study Coordinator, 18665730280
- Completed
The Children's Hospital of Zhejiang University School of Medicine ( Site 0009)
Hangzhou, Zhejiang, 310003
- Recruiting
The First Hospital of Harbin ( Site 0005)
Harbin, Heilongjiang, 150010
Study Coordinator, 045184883472
- Recruiting
The Second Hospital of Hebei Medical University ( Site 0003)
Shijiazhuang, Hebei, 050000
Study Coordinator, 0311-66002778
- Recruiting
Hematology Hospital of Chinese Academy of Medical Sciences ( Site 0001)
Tianjin, Tianjin Municipality, 301617
Study Coordinator, 022 23608030
- Recruiting
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology ( Site 0010)
Wuhan, Hubei, 430022
Study Coordinator, 02785726114
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of HUST ( Site 0006)
Wuhan, Hubei, 430030
Study Coordinator, 02783662640
- Active, not recruiting
The Affiliated Hospital of Xuzhou Medical University ( Site 0007)
Xuzhou, Jiangsu, 221002
- Recruiting
Henan Cancer Hospital-hematology department ( Site 0002)
Zhengzhou, Henan, 450008
Study Coordinator, 400037818
About this study
Official title: 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- MK-1045
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1045Drug
Also called CN201
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. Following each consolidation and maintenance cycle, there are treatment-free intervals ranging 2-8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MK-1045: Dose Escalation Phase- Adult Cohort | Experimental | Adults in the dose escalation phase will receive a target dose level of MK-1045 from 600 μg to 120,000 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. Receives: Drug: MK-1045 |
| MK-1045 : Dose Escalation Phase- Pediatric Cohort | Experimental | 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. Receives: Drug: MK-1045 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation Phase: Number of Participants who Experience at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to approximately 24 months
Dose Escalation Phase: Number of Participants who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to approximately 21 months
Dose Escalation Phase: Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
A DLT is defined as any of the following toxicities and judged by the investigator to be related to the study drug:
Hematologic toxic reactions: Due to the influence of the primary disease (leukemia), thrombocytopenia, leukopenia, and anemia are not considered as DLTs.
Non-Hematologic toxic reactions: Grade 4 non-hematologic toxicity that does not recover to ≤ Grade 2 within 14 days of best supportive therapy. Grade 3 rash, fatigue, fever, or infection will not be classified as DLT; other Grade 3 non-hematologic toxicities that do not recover to ≤ Grade 2 within 14 days of best supportive therapy is considered DLTs.
Others that are considered as DLTs: Other toxicities considered by the investigator that result in permanent drug withdrawal.
Measured: Up to 28 days
Dose Escalation Phase: Maximum Tolerated Dose (MTD) of MK-1045
The MTD will be determined based on the incidence of DLT in each dose level. The dose level for which the DLT rate is closest to the target DLT rate (30%) will be selected as the MTD.
Measured: Up to approximately 21 months
Phase II: Complete Remission (CR) Rate
Complete remission is defined as follows:
< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10^9/L, and absolute neutrophil count (ANC) ≥1.0×10^9/L. The number of participants with CR will be presented.
Measured: Up to approximately 10 weeks
Secondary outcomes (37)
Dose Escalation Phase: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-1045
Blood samples will be collected to determine the AUC from time 0 to the last concentration that can be accurately measured of MK-1045
Measured: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1045
Blood samples will be collected to determine the AUC0-inf of MK-1045.
Measured: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Area Under the Concentration-time Curve From Time 0 to 168 hours (AUC0-168)
Blood samples will be collected to determine the AUC from time to 168 hours after the start of infusion of MK-1045
Measured: At designated time points up to approximately 24 weeks
Dose Escalation Phase: AUC From Time 0 to 168 Hours at Steady State (AUC0-tau)
Blood samples will be collected to determine the AUC0 -tau
Measured: At designated time points up to 24 weeks
Dose Escalation Phase: Maximum Serum Drug Concentration (Cmax) of MK-1045
Blood samples will be collected to determine the maximum serum drug concentration, obtained directly from the measured value of the plasma concentration-time curve
Measured: At designated time points up to approximately 32 weeks
Dose Escalation Phase: Time to Maximum Serum Drug Concentration of MK-1045
Blood samples will be collected to determine the Tmax of MK-1045
Measured: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Concentration at End of Dosing Interval (Ctrough) of MK-1045
Blood samples will be collected to determine the Ctrough of MK-1045
Measured: At designated time points up to approximately 12 months
Dose Escalation Phase: Apparent Terminal Half Life (t1/2)
Blood samples will be collected to determine the t1/2 of MK-1045
Measured: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Apparent Clearance (CL) of MK-1045
Blood samples will be collected to determine the CL of MK-1045
Measured: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Apparent Volume of Distribution (Vz) of MK-1045
Blood samples will be collected to determine the Vz of MK-1045
Measured: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Apparent Volume of Distribution at Theoretical Steady State (Vss) of MK-1045
Blood samples will be collected to determine the Vss of MK-1045
Measured: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Mean Residence Time (MRT) of MK-1045
Blood samples will be collected to determine the MRT of MK-1045
Measured: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Peripheral B Cell Depletion of MK-1045
B cell depletion will be determined at each timepoint by comparing absolute B cell numbers (as determined by flow cytometry) with those at baseline
Measured: Baseline and at designated time points up to approximately 12 months
Dose Escalation Phase: Peripheral Circulating T Cell Activation of of MK-1045
Peripheral circulating T cell activation will be determined at each timepoint by comparing absolute T cell numbers and T cell activation markers with those at baseline
Measured: Baseline and at designated time points up to approximately 12 months
Dose Escalation Phase: Percentage of Participants with Antidrug Antibodies (ADA) to MK-1045
Blood samples collected at designated timepoints will be used to determine the percentage of participants who develop detectable ADAs to MK-1045
Measured: At designated time points up to approximately 12 months
Dose Escalation Phase: Rate of Complete Remission (CR) and Complete Remission with Partial Hematologic Recovery (CRh)
Complete remission is defined as follows:
< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10^9/L, and absolute neutrophil count (ANC) ≥1.0×10^9/L.
CRh is defined as meeting all of the following criteria:
Satisfaction of all criteria for CR except partial recovery of peripheral blood counts (platelets ≥ 50 ×10^9/L and ANC ≥ 0.5×10^9/L). The percentage of participants with CR or CRh will be presented.
Measured: Up to approximately 10 weeks
Dose Escalation Phase: Rate of CR, CRh, and Complete Response with Incomplete Hematologic Recovery (CRi)
Complete remission is defined as follows:
< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10^9/L, and absolute neutrophil count (ANC) ≥1.0×10^9/L.
CRh is defined as meeting all of the following criteria:
Satisfaction of all criteria for CR except partial recovery of peripheral blood counts (platelets ≥ 50 ×10^9/L and ANC ≥ 0.5×10^9/L).
CRi is defined as follows:
<5% blasts in the bone marrow, No circulating lymphoblasts or extramedullary disease, and platelets <100×10^9/L and neutrophils ≥1.0×109/L or platelets ≥100 ×109/L and neutrophils <1.0×10^9/L. The percentage of participants with CR, CRh or CRi will be presented.
Measured: Up to approximately 10 weeks
Dose Escalation Phase: Rate of Minimum Residual Disease (MRD)-negative Complete Remission
MRD-negative is defined as less than 0.01% of leukemic cells were detected in bone marrow with a detection sensitivity no less than 10^-4.
Measured: Up to approximately 12 months
Dose Escalation Phase: Rate of Red Blood Cell and Platelet Transfusion Independence (TI)
TI is defined as no transfusion for a period of at least 1 week (7 days). The percentage of participants having TI will be presented.
Measured: Up to approximately 24 months
Phase II: Number of Participants Who Experience at Least 1 AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to approximately 24 months
Phase II: Number of Participants who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to approximately 24 months
Phase II: Maximum Serum Drug Concentration (Cmax) of MK-1045
Blood samples will be collected to determine the maximum serum drug concentration, obtained directly from the measured value of the plasma concentration-time curve
Measured: At designated time points up to 4 weeks
Phase II: Concentration at End of Dosing Interval (Ctrough) of MK-1045
Blood samples will be collected to determine the Ctrough of MK-1045
Measured: At designated time points up to 4 weeks
Phase II: Peripheral B Cell Depletion of MK-1045
B cell depletion will be determined at each timepoint by comparing absolute B cell numbers (as determined by flow cytometry) with those at baseline
Measured: Baseline and at designated time points up to 4 weeks
Phase II: Peripheral Circulating T Cell Activation of of MK-1045
Peripheral circulating T cell activation will be determined at each timepoint by comparing absolute T cell numbers and T cell activation markers with those at baseline
Measured: Baseline and at designated time points up to 4 weeks
Phase II: Concentration of Peripheral Cytokines
Blood samples will be collected to compare peripheral blood cytokine levels at various time points with those at baseline
Measured: Baseline and at designated time points up to 4 weeks
Phase II: Percentage of participants with Antidrug Antibodies (ADA) to MK-1045
Blood samples collected at designated timepoints will be used to determine the percentage of participants who develop detectable ADAs to MK-1045
Measured: At designated time points up to 4 weeks
Phase II: Rate of CR and CRh
Complete remission is defined as follows:
< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10^9/L, and absolute neutrophil count (ANC) ≥1.0×10^9/L.
CRh is defined as meeting all of the following criteria:
Satisfaction of all criteria for CR except partial recovery of peripheral blood counts (platelets ≥ 50 ×10^9/L and ANC ≥ 0.5×10^9/L). The percentage of participants with CR or CRh will be presented.
Measured: Up to approximately 10 weeks
Phase II: Rate of CR/CRh/CRi
CR is defined as follows:
< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10^9/L, and absolute neutrophil count (ANC) ≥1.0×10^9/L.
CRh is defined as meeting all of the following criteria:
Satisfaction of all criteria for CR except partial recovery of peripheral blood counts (platelets ≥ 50 ×10^9/L and ANC ≥ 0.5×10^9/L).
CRi is defined as follows:
<5% blasts in the bone marrow, No circulating lymphoblasts or extramedullary disease, and platelets <100×10^9/L and neutrophils ≥1.0×109/L or platelets ≥100 ×109/L and neutrophils <1.0×10^9/L. The percentage of participants with CR, CRh or CRi will be presented.
Measured: Up to approximately 10 weeks
Phase II: Rate of Minimum Residual Disease (MRD)-negative Complete Remission
MRD-negative is defined as less than 0.01% of leukemic cells were detected in bone marrow with a detection sensitivity no less than 10^-4.
Measured: Up to approximately 24 months
Phase II: Rate of Red Blood Cell and Platelet TI
Red Blood Cell and Platelet TI is defined as no transfusion for a period of at least 1 week (7 days). The percentage of participants having TI will be presented.
Measured: Up to approximately 24 months
Phase II: Proportion of Participants Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
The number of participants who undergo a HSCT during study participation will be presented.
Measured: Up to approximately 24 months
Phase II: Duration of CR
For participants who demonstrate a CR (defined as < 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10^9/L, and absolute neutrophil count (ANC) ≥1.0×10^9/L) , duration of CR is defined as the time from the first documentation of a disease response of CR to the date of the first documented relapse event, or death due to any cause, whichever occurs first
Measured: Up to approximately 24 months
Phase II: Duration of CR/CRh
Duration of CR/CRh is defined as the time from the first documentation of a disease response of CR/CRh to the date of the first documented relapse event, or death due to any cause, whichever occurs first. Only participants who demonstrate a CR (defined as < 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10^9/L, and absolute neutrophil count (ANC) ≥1.0×10^9/L), or CRh [satisfaction of all criteria for CR except partial recovery of peripheral blood counts (platelets ≥ 50 ×10^9/L and ANC ≥ 0.5×10^9/L)] will be analyzed.
Measured: Up to approximately 24 months
Phase II: Duration of CR/CRh/CRi
Duration of CR/CRh/CRi is defined as the time from the first documentation of a disease response of CR/CRh/CRi to the date of the first documented relapse event, or death due to any cause, whichever occurs first. Only participants who demonstrate a CR (defined as < 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10^9/L, and absolute neutrophil count (ANC) ≥1.0×10^9/L), or CRh [satisfaction of all criteria for CR except partial recovery of peripheral blood counts (platelets ≥ 50 ×10^9/L and ANC ≥ 0.5×10^9/L)], or CRi (<5% blasts in the bone marrow, No circulating lymphoblasts or extramedullary disease, and platelets <100×10^9/L and neutrophils ≥1.0×109/L or platelets ≥100 ×109/L and neutrophils <1.0×10^9/L) will be analyzed.
Measured: Up to approximately 24 months
Phase II: Relapse-Free Survival (RFS)
RFS is defined as the time from the first dose of MK-1045 to the first documented relapse, or death due to any cause (whichever occurs first). In participants who achieve CR, CRh or CRi, relapse is defined as either hematological or extramedullary relapse . Hematological relapse is defined as recurrence of blasts in the blood, or >5% blasts in bone marrow. Extramedullary relapse is defined as recurrence of extramedullary disease after a CR.
Measured: Up to approximately 24 months
Phase II: Overall Survival (OS)
OS is the time from date of first study treatment to the date of death due to any reason.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MSD R&D (China) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianxiang Wang, Dr., Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579132
- Sponsor's protocol ID
- 1045-002
- Other IDs
- MK-1045-002, CN201-103
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Phase Ib/II Study of MK-1045 (CN201) in Subjects With Precursor B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05579132
- Acronym / sponsor ID
- 1045-002
- Conditions
- Acute Lymphoblastic Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 203 participants (estimated)
- Lead sponsor
- MSD R&D (China) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-1045: Dose Escalation Phase- Adult Cohort | Experimental | Drug: MK-1045Adults in the dose escalation phase will receive a target dose level of MK-1045 from 600 μg to 120,000 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. |
| MK-1045 : Dose Escalation Phase- Pediatric Cohort | Experimental | Drug: MK-1045Pediatric 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. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-1045Also: CN201MK-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. Following each consolidation and maintenance cycle, there are treatment-free intervals ranging 2-8 weeks. | Drug | MK-1045 : Dose Escalation Phase- Pediatric Cohort, MK-1045: Dose Escalation Phase- Adult Cohort |
Primary outcome
Dose Escalation Phase: Number of Participants who Experience at Least One Adverse Event (AE)
Time frame: Up to approximately 24 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Dose Escalation Phase: Number of Participants who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 21 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Dose Escalation Phase: Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Time frame: Up to 28 days
A DLT is defined as any of the following toxicities and judged by the investigator to be related to the study drug: Hematologic toxic reactions: Due to the influence of the primary disease (leukemia), thrombocytopenia, leukopenia, and anemia are not considered as DLTs. Non-Hematologic toxic reactions: Grade 4 non-hematologic toxicity that does not recover to ≤ Grade 2 within 14 days of best supportive therapy. Grade 3 rash, fatigue, fever, or infection will not be classified as DLT; other Grade 3 non-hematologic toxicities that do not recover to ≤ Grade 2 within 14 days of best supportive therapy is considered DLTs. Others that are considered as DLTs: Other toxicities considered by the investigator that result in permanent drug withdrawal.
Dose Escalation Phase: Maximum Tolerated Dose (MTD) of MK-1045
Time frame: Up to approximately 21 months
The MTD will be determined based on the incidence of DLT in each dose level. The dose level for which the DLT rate is closest to the target DLT rate (30%) will be selected as the MTD.
Phase II: Complete Remission (CR) Rate
Time frame: Up to approximately 10 weeks
Complete remission is defined as follows: < 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10^9/L, and absolute neutrophil count (ANC) ≥1.0×10^9/L. The number of participants with CR will be presented.
37 secondary outcomes
Dose Escalation Phase: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Area Under the Concentration-time Curve From Time 0 to 168 hours (AUC0-168)
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: AUC From Time 0 to 168 Hours at Steady State (AUC0-tau)
Time frame: At designated time points up to 24 weeks
Dose Escalation Phase: Maximum Serum Drug Concentration (Cmax) of MK-1045
Time frame: At designated time points up to approximately 32 weeks
Dose Escalation Phase: Time to Maximum Serum Drug Concentration of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Concentration at End of Dosing Interval (Ctrough) of MK-1045
Time frame: At designated time points up to approximately 12 months
Dose Escalation Phase: Apparent Terminal Half Life (t1/2)
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Apparent Clearance (CL) of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Apparent Volume of Distribution (Vz) of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Apparent Volume of Distribution at Theoretical Steady State (Vss) of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Mean Residence Time (MRT) of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Peripheral B Cell Depletion of MK-1045
Time frame: Baseline and at designated time points up to approximately 12 months
Dose Escalation Phase: Peripheral Circulating T Cell Activation of of MK-1045
Time frame: Baseline and at designated time points up to approximately 12 months
Dose Escalation Phase: Percentage of Participants with Antidrug Antibodies (ADA) to MK-1045
Time frame: At designated time points up to approximately 12 months
Dose Escalation Phase: Rate of Complete Remission (CR) and Complete Remission with Partial Hematologic Recovery (CRh)
Time frame: Up to approximately 10 weeks
Dose Escalation Phase: Rate of CR, CRh, and Complete Response with Incomplete Hematologic Recovery (CRi)
Time frame: Up to approximately 10 weeks
Dose Escalation Phase: Rate of Minimum Residual Disease (MRD)-negative Complete Remission
Time frame: Up to approximately 12 months
Dose Escalation Phase: Rate of Red Blood Cell and Platelet Transfusion Independence (TI)
Time frame: Up to approximately 24 months
Phase II: Number of Participants Who Experience at Least 1 AE
Time frame: Up to approximately 24 months
Phase II: Number of Participants who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 24 months
Phase II: Maximum Serum Drug Concentration (Cmax) of MK-1045
Time frame: At designated time points up to 4 weeks
Phase II: Concentration at End of Dosing Interval (Ctrough) of MK-1045
Time frame: At designated time points up to 4 weeks
Phase II: Peripheral B Cell Depletion of MK-1045
Time frame: Baseline and at designated time points up to 4 weeks
Phase II: Peripheral Circulating T Cell Activation of of MK-1045
Time frame: Baseline and at designated time points up to 4 weeks
Phase II: Concentration of Peripheral Cytokines
Time frame: Baseline and at designated time points up to 4 weeks
Phase II: Percentage of participants with Antidrug Antibodies (ADA) to MK-1045
Time frame: At designated time points up to 4 weeks
Phase II: Rate of CR and CRh
Time frame: Up to approximately 10 weeks
Phase II: Rate of CR/CRh/CRi
Time frame: Up to approximately 10 weeks
Phase II: Rate of Minimum Residual Disease (MRD)-negative Complete Remission
Time frame: Up to approximately 24 months
Phase II: Rate of Red Blood Cell and Platelet TI
Time frame: Up to approximately 24 months
Phase II: Proportion of Participants Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
Time frame: Up to approximately 24 months
Phase II: Duration of CR
Time frame: Up to approximately 24 months
Phase II: Duration of CR/CRh
Time frame: Up to approximately 24 months
Phase II: Duration of CR/CRh/CRi
Time frame: Up to approximately 24 months
Phase II: Relapse-Free Survival (RFS)
Time frame: Up to approximately 24 months
Phase II: Overall Survival (OS)
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianxiang Wang, Dr. principal investigator
Institute of Hematology & Blood Diseases Hospital, China
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MK-1045 in people with Acute Lymphoblastic Leukemia, run by MSD R&D (China) Co., Ltd. at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation Phase: Number of Participants who Experience at Least One Adverse Event (AE) (time frame: Up to approximately 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.