New drug combo targets rare blood cancers

NCT ID NCT06034002

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage trial tests a new drug called INCA033989, alone or with an existing drug (ruxolitinib), in people with myeloproliferative neoplasms—a group of rare blood cancers that cause the bone marrow to produce too many cells. The study aims to find safe doses and check for side effects in about 290 participants. It is not yet testing whether the drug works, but it is a first step toward a potential new treatment.

What this could mean

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

Active substance
INCA033989 (a drug) and ruxolitinib (also known as Jakafi)
What this could lead to
If successful, this could lead to a new treatment option for people with myeloproliferative neoplasms, potentially improving symptom control and reducing spleen size.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, not yet on effectiveness. The drug may cause side effects or not work as hoped. Results are preliminary and may not lead to a widely available treatment.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 290 people

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

Started

Dec 2023

Expected to finish

Oct 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

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: * Life expectancy \> 6 months. * Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease). * Existing documentation from a qualified local laboratory of CALR exon-9 mutation. * Participants with MF or ET as defined in the protocol. Exclusion Criteria: * Presence of any hematological malignancy other than ET, PMF, or post-ET MF. * Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment. * Participants with laboratory values exceeding the protocol defined thresholds. * Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned. * Active invasive malignancy over the previous 2 years. * History of clinically significant or uncontrolled cardiac disease. * Active or chronic HBV or active HCV or known history of HIV. * Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease, with the exception of ruxolitinib for TGBs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. * Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment. Other protocol-defined Inclusion/Exclusion Criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    13 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: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Icahn School of Medicine At Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Stanford Cancer Institute

    RECRUITING

    Palo Alto, California, 94304, United States

  • The University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Miami Health System

    RECRUITING

    Miami, Florida, 33136, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Wake Forest Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63108, United States

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