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Recruiting NCT05579132

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

Phase I / Phase II Interventional Acute Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MK-1045.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • Dose Escalation Phase: Number of Participants who Experience at Least One Adverse Event (AE) [Time frame: Up to approximately 24 months]
  • Dose Escalation Phase: Number of Participants who Discontinue Study Treatment Due to an AE [Time frame: Up to approximately 21 months]
  • Dose Escalation Phase: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) [Time frame: Up to 28 days]
  • Dose Escalation Phase: Maximum Tolerated Dose (MTD) of MK-1045 [Time frame: Up to approximately 21 months]
  • Phase II: Complete Remission (CR) Rate [Time frame: Up to approximately 10 weeks]
Secondary outcome measures (12)
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 11 centers
  • The Second Affiliated Hospital of Third Military Medical University ( Site 0008) — Chongqing
  • Southern Medical University Nanfang Hospital ( Site 0004) — Guangzhou
  • The Second Hospital of Hebei Medical University ( Site 0003) — Shijiazhuang
  • The First Hospital of Harbin ( Site 0005) — Harbin
  • Henan Cancer Hospital-hematology department ( Site 0002) — Zhengzhou
  • Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and — Wuhan
  • Tongji Hospital affiliated to Tongji Medical College of HUST ( Site 0006) — Wuhan
  • The Affiliated Hospital of Xuzhou Medical University ( Site 0007) — Xuzhou
  • … and 3 more centers

Identifiers

NCT: NCT05579132 · 1045-002 · MK-1045-002 · CN201-103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗