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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT06150157

Registry updated: 2026-09-25
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Description

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.

Interventions

  • JNJ-88549968 (Drug)
    JNJ-88549968 will be administered.
  • Ruxolitinib (Drug)
    For US sites: Ruxolitinib will be administered for participants with MF only.
  • Momelotinib (Drug)
    For US sites: Momelotinib will be administered for participants with MF only.

Eligibility criteria

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

Conditions

Neoplasms

Locations

  • City of Hope — Duarte, California, United States
  • UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center — Aurora, Colorado, United States
  • Moffit Cancer center — Tampa, Florida, United States
  • Emory University — Atlanta, Georgia, United States
  • University of Michigan — Ann Arbor, Michigan, United States
  • Start Midwest — Grand Rapids, Michigan, United States
  • START New Jersey — East Brunswick, New Jersey, United States
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Montefiore Medical Center — The Bronx, New York, United States
  • Levine Cancer Institute — Charlotte, North Carolina, United States
  • University of Pennsylvania — Philadelphia, Pennsylvania, United States
  • Prisma Health — Greenville, South Carolina, United States
  • Sarah Cannon Cancer Institute — Nashville, Tennessee, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • Swedish Cancer Institute — Seattle, Washington, United States
  • Arthur J E Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
  • Princess Margaret Cancer Centre University Health Network — Toronto, Ontario, Canada
  • Jewish General Hospital — Montreal, Quebec, Canada
  • Peking Union Medical College Hospital — Beijing, China
  • The First Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, China
  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin, China
  • Hopital Saint Louis — Paris, France
  • CH LYON SUD - Hematology — Pierre-Bénite, France
  • Institut Universitaire du Cancer Toulouse Oncopole — Toulouse, 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
  • Juntendo University Hospital — Bunkyō City, Japan
  • National Cancer Center Hospital East — Kashiwa, Japan
  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record