Myeloproliferative Neoplasms Clinical Trial

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

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).

View Eligibility Criteria

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:

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

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT06150157

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 4 Locations for this study

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City of Hope
Duarte California, 91010, United States
Sarah Cannon Cancer Institute
Nashville Tennessee, 37203, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
University Health Network (UHN) Princess Margaret Cancer Centre
Toronto Ontario, M5G 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

100

Study ID:

NCT06150157

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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