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NeoplasmsPhase 1NCT06150157

A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

A Phase 1 study testing JNJ-88549968, Ruxolitinib and Momelotinib in people with Neoplasms, run by Janssen Research & Development, LLC at 46 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D[s]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
JNJ-88549968, Ruxolitinib and Momelotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
46 sitesin 10 countries
Study dates
20 Dec 2023to 14 Jun 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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:
  • Prior treatment with allogenic stem cell transplant less than or equal to (<=) 6 months before the first dose of JNJ-88549968 or
  • 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

Trial locations and contacts

46 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

46 sites in 10 countries

United States18 sites, 18 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Recruiting

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

    Aurora, Colorado, 80045

    Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Recruiting

  • START New Jersey

    East Brunswick, New Jersey, 08816

    Recruiting

  • City of Hope Phoenix

    Goodyear, Arizona, 85338

    Recruiting

  • Start Midwest

    Grand Rapids, Michigan, 49546

    Recruiting

  • Prisma Health

    Greenville, South Carolina, 29605

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Sarah Cannon Cancer Institute

    Nashville, Tennessee, 37203

    Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Recruiting

  • Moffit Cancer center

    Tampa, Florida, 33612

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Recruiting

  • City of Hope Chicago

    Zion, Illinois, 60099

    Recruiting

Other trials in United States

Germany6 sites, 6 recruiting

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074

    Recruiting

  • Charite Campus Benjamin Franklin

    Berlin, 12203

    Recruiting

  • Med. Universitatsklinik Essen

    Essen, 45147

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Recruiting

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

    Recruiting

  • Universitaetsklinikum Regensburg

    Regensburg, 93053

    Recruiting

Other trials in Germany

Israel4 sites, 4 recruiting

  • Carmel Medical Center

    Haifa, 3436212

    Recruiting

  • Hadassah University Hospita Ein Kerem

    Jerusalem, 9112001

    Recruiting

  • Sheba Medical Center

    Ramat Gan, 5266202

    Recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

    Recruiting

Other trials in Israel

Canada3 sites, 2 recruiting

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 4N1

    Recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Completed

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G 1Z5

    Recruiting

Other trials in Canada

China3 sites, 3 recruiting

  • Peking Union Medical College Hospital

    Beijing, 100032

    Recruiting

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310002

    Recruiting

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

    Tianjin, 301617

    Recruiting

Other trials in China

France3 sites, 3 recruiting

  • Hopital Saint Louis

    Paris, 75475

    Recruiting

  • CH LYON SUD - Hematology

    Pierre-Bénite, 69495

    Recruiting

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059

    Recruiting

Other trials in France

United Kingdom3 sites, 3 recruiting

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2PG

    Recruiting

  • Guy's and St Thomas' Hospital

    London, SE1 9RT

    Recruiting

  • Churchill Hospital

    Oxford, OX3 7LE

    Recruiting

Other trials in United Kingdom

Italy2 sites, 2 recruiting

  • Policlinico Sant'Orsola Malpighi

    Bologna, 40138

    Recruiting

  • Policlinico di Milano

    Milan, 21022

    Recruiting

Other trials in Italy

Japan2 sites, 2 recruiting

  • Juntendo University Hospital

    Bunkyō City, 113 8431

    Recruiting

  • National Cancer Center Hospital East

    Kashiwa, 277 8577

    Recruiting

Other trials in Japan

Spain2 sites, 2 recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916

    Recruiting

  • Hosp. Clinico Univ. de Valencia

    Valencia, 46010

    Recruiting

Other trials in Spain

About this study

Official title: A First-in-Human Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ 88549968, a T-cell Redirecting Bispecific Antibody for CALR-mutated Myeloproliferative Neoplasms

The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D[s]) and optimal dosing schedule(s) of JNJ-88549968 in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s) in part 2 (Cohort Expansion). For U.S. sites: the purpose of this study is to characterize the safety and to determine the RP2D(s) and optimal dosing schedule(s) of JNJ-88549968 in Part 1 and part 1b (Dose Escalation), and to characterize the safety of JNJ-88549968 at the RP2D(s) in Part 2 and part 2b (Cohort Expansion), when given as monotherapy in essential thrombocythemia (ET) or myelofibrosis (MF), and with ruxolitinib or momelotinib in MF only.

Conditions
Neoplasms
Being tested
JNJ-88549968, Ruxolitinib, Momelotinib
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-88549968Drug

    JNJ-88549968 will be administered.

  • RuxolitinibDrug

    For US sites: Ruxolitinib will be administered for participants with MF only.

  • MomelotinibDrug

    For US sites: Momelotinib will be administered for participants with MF only.

Study groups in NCT06150157
Study groupRoleWhat they receive
Dose Escalation (Part 1), Dose Expansion (Part 2) and Part 1b (US only), Part 2b (US only)ExperimentalIn dose escalation (Part 1), participants will receive JNJ-88549968. For myelofibrosis (MF) participants only, the study will explore a Phase 1b cohort in which the janus kinase (JAK) inhibitor ruxolitinib or momelotinib is started in combination with JNJ-88549968. The dose will be escalated sequentially to determine the recommended phase 2 dose (RP2D) and optimal dosing schedule (s) based on safety, pharmacokinetic, pharmacodynamic, and preliminary assessment of efficacy across several dose regimens. Additional Cohorts may be added to assess different formulation or delivery methods. In dose expansion (Part 2, Part 2b [US only]), participants will receive JNJ-88549968 at the RP2D regimen(s) determined in dose escalation (Part 1, Part 1b [US only]).
Receives: Drug: JNJ-88549968; Drug: Ruxolitinib; Drug: Momelotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1, Part 1b (US Only): Number of Participants With Dose Limiting Toxicity (DLT)

    Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. For US only: A DLT is any adverse event attributed to study treatment that meets the criteria for severity and duration and that occurs during the evaluation periods unless it can be incontrovertibly attributed to disease or other extraneous cause such as an accident.

    Measured: Approximately up to 35 days after first dose of study treatment

  2. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

    Measured: Up to 2 years

  3. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs) by Severity

    An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. Cytokine release syndrome (CRS) and associated neurologic toxicity events (immune effector cell-associated neurotoxicity syndrome events [ICANS]) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.

    Measured: Up to 2 years

Secondary outcomes (7)

  1. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Serum Concentration of JNJ-88549968

    Serum samples will be analyzed to determine concentrations of JNJ-88549968.

    Measured: Up to 2 years

  2. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants With Presence of Anti-Drug Antibodies to JNJ-88549968

    Number of participants with presence of anti-drug antibodies to JNJ-88549968 will be reported.

    Measured: Up to 2 years

  3. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Overall Response Rate

    ORR is defined as the percentage of participants who achieve partial response (PR) and complete response (CR) according to modified International Working Group-Myeloproliferative Neoplasm Research and Treatment (IWG-MRT) criteria and modified European Leukemia Net (ELN) consensus report.

    Measured: Up to 2 years

  4. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Complete Response (CR) Rate

    CR rate is defined as the percentage of participants who achieve a best response of CR according to disease as defined in modified IWG-MRT criteria and modified ELN consensus report.

    Measured: Up to 2 years

  5. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Time to Response (TTR)

    TTR is defined for participants who achieved PR or CR as the time from the first dose of study treatment to first response of PR or CR according to modified IWG-MRT criteria and modified ELN consensus report.

    Measured: Up to 2 years

  6. Part 1, 2, Part 1b (US Only), Part 2b (US Only): Duration of Response (DOR)

    DOR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of first documented evidence of disease progression, as defined in modified IWG-MRT criteria and modified ELN consensus report, or death, whichever comes first.

    Measured: Up to 2 years

  7. Part 2, Part 2b (US Only): Change From Baseline in Myeloproliferative Neoplasm (MPN) Symptom Burden

    Change from baseline in MPN symptom burden assessed using patient reported outcome (PRO) questionnaire will be reported in this outcome measure.

    Measured: Baseline up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2023
  2. Study start20 Dec 2023
  3. Primary completion14 Jun 2027 (estimated)
  4. Study completion14 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06150157
Sponsor's protocol ID
88549968MPN1001
Other IDs
88549968MPN1001, 2023-505584-36-00, 2023
Status last verified
Nov 2026
First submitted
21 Nov 2023
Last updated
4 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-88549968, Ruxolitinib and Momelotinib in people with Neoplasms, run by Janssen Research & Development, LLC at 46 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Germany, Israel, Canada, China and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1, Part 1b (US Only): Number of Participants With Dose Limiting Toxicity (DLT) (time frame: Approximately up to 35 days after first dose of study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06150157.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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