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New biologic MK-1045 targets Hard-to-Treat blood cancers

NCT ID NCT07709000

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This phase 2 trial tests an experimental biologic called MK-1045 in people with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study aims to see if MK-1045 is safe and tolerable, and how many participants respond to treatment. Participants receive MK-1045 by intravenous infusion, along with premedications to reduce side effects.

What this could mean

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

Active substance
a biologic called MK-1045 (also known as CN201)
What this could lead to
If successful, MK-1045 could offer a new treatment option for people with hard-to-treat CLL or SLL.
What could go wrong
This is an early-phase trial with only 60 participants, so results may not apply broadly. Side effects and lack of response are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2033

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

18 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.

Inclusion Criteria: * Has histologically confirmed chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) active disease that is relapsed/refractory (r/r) to prior therapy. * Has confirmed CD19-positive disease. * If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy. * If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load. * If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load. Exclusion Criteria: * Has a history of serious cardiovascular and cerebrovascular diseases. * Has a history or presence of central nervous system disease. * Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has a diagnosis of immunodeficiency. * Has a known additional malignancy that is progressing or required active treatment within the past 2 years. * Has active autoimmune disease (not related to underlying leukemia diagnosis) that required systemic treatment in the past 2 years. * Has any active acute graft versus host disease (GvHD) or active chronic GvHD requiring systemic treatment. * Has active infection requiring systemic therapy. * Has not adequately recovered from major surgery or has ongoing surgical complications. * Has a diagnosis of Richter Transformation.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia hematopoietic and lymphoid system neoplasm Leukemia, B-Cell

As listed by the trial registrant

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

Chronic lymphocytic leukaemia Hematologic malignancies Small lymphocytic lymphoma

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

    3 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

  • Haddasah Medical Center ( Site 0800)

    Jerusalem, 9112001, Israel

  • Sheba Medical Center ( Site 0802)

    Ramat Gan, 5265601, Israel

  • Sourasky Medical Center ( Site 0804)

    Tel Aviv, 6423906, Israel

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