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

MSD R&D (China) Co., Ltd.

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: MK-1045

Study type: Interventional

Funder types: Industry

Identifiers

NCT05579132

CN201-103

1045-002

MK-1045-002 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 203 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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203 participants in 2 patient groups

MK-1045: Dose Escalation Phase- Adult Cohort

Experimental group

Description:

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.

Treatment:

Drug: MK-1045

MK-1045 : Dose Escalation Phase- Pediatric Cohort

Experimental group

Description:

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.

Treatment:

Drug: MK-1045