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

Recruiting now · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT06150157

Run by

Janssen Research & Development, LLC

People needed

241

Starts

2023-12-20

Expected to finish

2028-06-14

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• UCHealth Cancer Care Anschutz Medical Campus University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• Moffit Cancer center — Tampa, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Start Midwest — Grand Rapids, Michigan, United States (enrolling)
• START New Jersey — East Brunswick, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Sarah Cannon Cancer Institute — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Princess Margaret Cancer Centre University Health Network — Toronto, Ontario, Canada (enrolling)
• Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
• Peking Union Medical College Hospital — Beijing, China (enrolling)
• Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin, China (enrolling)
• Hopital Saint Louis — Paris, France (enrolling)
• CH LYON SUD - Hematology — Pierre-Bénite, France (enrolling)
• Institut Universitaire du Cancer Toulouse Oncopole — Toulouse, France (enrolling)
• Universitaetsklinikum der RWTH Aachen — Aachen, Germany (enrolling)
• Charite Campus Benjamin Franklin — Berlin, Germany (enrolling)
• Med. Universitatsklinik Essen — Essen, Germany (enrolling)
• Medizinische Hochschule Hannover — Hanover, Germany (enrolling)
• Universitaetsklinikum Heidelberg — Heidelberg, Germany (enrolling)

Full record on ClinicalTrials.gov

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