A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
NCT ID: NCT06150157
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2023-12-20
2027-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation (Part 1) and Dose Expansion (Part 2)
In dose escalation (Part 1), participants will receive 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. In dose expansion (Part 2), participants will receive JNJ-88549968 at the RP2D regimen(s) determined in dose escalation (Part 1).
JNJ-88549968
JNJ-88549968 will be administered.
Interventions
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JNJ-88549968
JNJ-88549968 will be administered.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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City of Hope
Duarte, California, United States
Moffit Cancer center
Tampa, Florida, United States
University of Michigan
Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Cancer Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Princess Margaret Cancer Centre University Health Network
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Hopital Saint Louis
Paris, , France
CH LYON SUD - Hematology
Pierre-Bénite, , France
Universitaetsklinikum der RWTH Aachen
Aachen, , Germany
Charite Campus Benjamin Franklin
Berlin, , Germany
Med. Universitatsklinik Essen
Essen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Regensburg
Regensburg, , Germany
Carmel Medical Center
Haifa, , Israel
Hadassah University Hospita Ein Kerem
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Policlinico di Milano
Milan, , Italy
Hosp. Univ. Germans Trias I Pujol
Badalona, , Spain
Hosp. Clinico Univ. de Valencia
Valencia, , Spain
University College London Hospitals Nhs Foundation Trust
London, , United Kingdom
Guy's and St Thomas' Hospital
London, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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88549968MPN1001
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505584-36-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
88549968MPN1001
Identifier Type: -
Identifier Source: org_study_id