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New hope for Tough-to-Treat blood cancer: MK-1045 enters human trials

NCT ID NCT05579132

Disease control Sponsor: MSD R&D (China) Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This study tests a new drug called MK-1045 (CN201) in people with a type of blood cancer (B-cell acute lymphoblastic leukemia) that has come back or stopped responding to treatment. The trial has two parts: first, finding a safe dose, and then checking how well the drug works. About 203 participants, aged 2 and older, will receive the drug by IV infusion over several cycles.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-1045 (also called CN201), a drug given by IV infusion
What this could lead to
If it works, this could provide a new treatment option for people with B-ALL whose cancer has returned or stopped responding to current therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not work as hoped or could cause serious side effects. The results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 203 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia precursor B-cell acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute lymphoblastic leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

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

    RECRUITING

    Tianjin, Tianjin Municipality, 301617, China

  • Henan Cancer Hospital-hematology department ( Site 0002)

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Southern Medical University Nanfang Hospital ( Site 0004)

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • The Affiliated Hospital of Xuzhou Medical University ( Site 0007)

    ACTIVE_NOT_RECRUITING

    Xuzhou, Jiangsu, 221002, China

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

    COMPLETED

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Harbin ( Site 0005)

    RECRUITING

    Harbin, Heilongjiang, 150010, China

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

    RECRUITING

    Chongqing, Chongqing Municipality, 400037, China

  • The Second Hospital of Hebei Medical University ( Site 0003)

    RECRUITING

    Shijiazhuang, Hebei, 050000, China

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

    RECRUITING

    Wuhan, Hubei, 430030, China

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

    RECRUITING

    Wuhan, Hubei, 430022, China

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

    COMPLETED

    Chengdu, Sichuan, 610000, China

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