Status:
RECRUITING
A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Myeloproliferative Disorders
Essential Thrombocythemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 characteri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06150157
Start Date
December 20 2023
End Date
December 15 2027
Last Update
December 24 2025
Active Locations (29)
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1
City of Hope
Duarte, California, United States, 91010
2
Moffit Cancer center
Tampa, Florida, United States, 33612
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065