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

NCT05579132 | Recruiting Phase 1

• 3 other identifiers: 1045-002MK-1045-002CN201-103
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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: If thrombocytopenia, leukopenia, and anemia are caused by primary leukemia, they 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 clinically significant by the investigator that result in permanent drug withdrawal.

  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.

  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.

  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

  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

  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)

  At designated time points up to approximately 24 weeks

• Dose Escalation Phase: AUC From Time 0 to 168 Hours at Steady State (AUC0-tau)

  At designated time points up to 24 weeks

• Dose Escalation Phase: Maximum Serum Drug Concentration (Cmax) of MK-1045

  At designated time points up to approximately 32 weeks

Study Arms (2)

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.

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.

Drug: MK-1045

Interventions

MK-1045 DRUG

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.

Also known as: CN201

MK-1045 : Dose Escalation Phase- Pediatric Cohort; MK-1045: Dose Escalation Phase- Adult Cohort

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• History of clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the CNS or meninges
• 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

Sponsors & Collaborators

• MSD R&D (China) Co., Ltd.: lead

Study Sites (11)

The Second Affiliated Hospital of Third Military Medical University ( Site 0008)

Chongqing, Chongqing Municipality, 400037, China

RECRUITING

Southern Medical University Nanfang Hospital ( Site 0004)

Guangzhou, Guangdong, 510515, China

RECRUITING

The Second Hospital of Hebei Medical University ( Site 0003)

Shijiazhuang, Hebei, 050000, China

RECRUITING

The First Hospital of Harbin ( Site 0005)

Harbin, Heilongjiang, 150010, China

RECRUITING

Henan Cancer Hospital-hematology department ( Site 0002)

Zhengzhou, Henan, 450008, China

RECRUITING

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology ( Site 0010)

Wuhan, Hubei, 430022, China

RECRUITING

Tongji Hospital affiliated to Tongji Medical College of HUST ( Site 0006)

Wuhan, Hubei, 430030, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University ( Site 0007)

Xuzhou, Jiangsu, 221006, China

ACTIVE NOT RECRUITING

West China Second University Hospital, Sichuan University ( Site 0011)

Chengdu, Sichuan, 610000, China

COMPLETED

Hematology Hospital of Chinese Academy of Medical Sciences ( Site 0001)

Tianjin, Tianjin Municipality, 301617, China

RECRUITING

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

Hangzhou, Zhejiang, 310003, China

COMPLETED

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jianxiang Wang, Dr.

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 13, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (11)