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New antibody therapy targets rare blood cancers in first human trial

NCT ID NCT06150157

Disease control Sponsor: Janssen Research & Development, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 6 times

Summary

This early-stage study tests a new drug called JNJ-88549968, a bispecific antibody designed to direct the body's immune T cells to attack cancer cells with a specific CALR mutation. The trial will enroll about 220 adults with essential thrombocythemia or myelofibrosis who carry this mutation. The main goals are to check the drug's safety, find the best dose, and see how the body processes it.

What this could mean

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

Active substance
JNJ-88549968 (a bispecific antibody that redirects T cells to attack cancer cells), sometimes given with ruxolitinib or momelotinib
What this could lead to
If successful, this could lead to a new targeted treatment option for people with certain rare blood cancers that have not responded to standard therapies.
What could go wrong
This is a very early Phase 1 trial focused on safety and dosing, so it is unknown if the drug will work. Side effects like cytokine release syndrome and other immune reactions are possible risks.

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 300 people

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

Started

Dec 2023

Expected to finish

Jun 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: * Be greater than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever the greater) at the time of informed consent * Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET) or myelofibrosis (MF) * Participants with ET and MF with risk characteristics as described in the protocol * Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of less than or equal to (\<=) 2 * For US sites: Eligible for ruxolitinib therapy as per drug label for participants naive to a janus kinase (JAK) inhibitor Exclusion Criteria: * Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment * Concurrent or recently diagnosed or treated malignancies present at the time of participant screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix, and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of study treatment in the opinion of both the investigator and sponsor's medical monitor. Participants cured of another malignant disease with no sign of relapse greater than or equal to (\>=) 3 years after treatment ended are allowed to enter the study * Prior solid organ transplantation * Either of the following regarding hematopoietic stem cell transplantation: 1. Prior treatment with allogenic stem cell transplant less than or equal to (\<=) 6 months before the first dose of JNJ-88549968 or 2. Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy * History of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

essential thrombocythemia myelofibrosis myeloproliferative neoplasm neoplasm

As listed by the trial registrant

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

Essential thrombocythemia Myelofibrosis Myeloproliferative disorders Neoplasms

How to take part

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

  1. The places running it

    41 sites in 10 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • CH LYON SUD - Hematology

    RECRUITING

    Pierre-Bénite, 69495, France

  • Carmel Medical Center

    RECRUITING

    Haifa, 3436212, Israel

  • Charite Campus Benjamin Franklin

    RECRUITING

    Berlin, 12203, Germany

  • Churchill Hospital

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Guy's and St Thomas' Hospital

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Hadassah University Hospita Ein Kerem

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hopital Saint Louis

    RECRUITING

    Paris, 75475, France

  • Hosp. Clinico Univ. de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hosp. Univ. Germans Trias I Pujol

    RECRUITING

    Badalona, 08916, Spain

  • Institut Universitaire du Cancer Toulouse Oncopole

    RECRUITING

    Toulouse, 31059, France

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, 301617, China

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Juntendo University Hospital

    RECRUITING

    Bunkyō City, 113 8431, Japan

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Med. Universitatsklinik Essen

    RECRUITING

    Essen, 45147, Germany

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Moffit Cancer center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, 277 8577, Japan

  • Peking Union Medical College Hospital

    RECRUITING

    Beijing, 100032, China

  • Policlinico Sant'Orsola Malpighi

    RECRUITING

    Bologna, 40138, Italy

  • Policlinico di Milano

    RECRUITING

    Milan, 21022, Italy

  • Princess Margaret Cancer Centre University Health Network

    RECRUITING

    Toronto, Ontario, M5G 1Z5, Canada

  • Prisma Health

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • START New Jersey

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Sarah Cannon Cancer Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 5266202, Israel

  • Start Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Swedish Cancer Institute

    RECRUITING

    Seattle, Washington, 98104, United States

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, 64239, Israel

  • UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Universitaetsklinikum Heidelberg

    RECRUITING

    Heidelberg, 69120, Germany

  • Universitaetsklinikum Regensburg

    RECRUITING

    Regensburg, 93053, Germany

  • Universitaetsklinikum der RWTH Aachen

    RECRUITING

    Aachen, 52074, Germany

  • University College London Hospitals Nhs Foundation Trust

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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