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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Nov 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called JNJ-88549968 for patients with certain blood disorders caused by a specific mutation known as calreticulin (CALR). These disorders include essential thrombocythemia (ET) and myelofibrosis (MF). The main goals of the study are to assess how safe the treatment is and to figure out the best dose for future studies.

To participate in this trial, you need to be at least 18 years old and have a CALR mutation. You'll also need to have a good level of health as measured by a specific performance scale. Participants will be closely monitored to see how well they tolerate the treatment and to collect important safety information. If you have any serious heart issues or have received certain types of cancer treatment recently, you may not be eligible. This study is currently recruiting participants, so if you or someone you know might be interested, it's a good idea to talk to a healthcare provider for more information.

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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
• 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