Clinical Trial

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

Recruiting Phase 1
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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). 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.
Protocol Amendment History 3 changes
notable Trial sites expanded: 33 -> 36 locations 2026-07-07
minor Completion pushed: 2028-05-12 -> 2028-06-14 2026-07-07
minor Completion pushed: 2028-04-12 -> 2028-05-12 2026-06-06
Trial Details
NCT Number NCT06150157
Lead Sponsor Janssen Research & Development, LLC
Conditions Neoplasms
Enrollment 241 participants
Start Date 2023-12-20
Primary Completion 2026-12-04 (estimated)
Study Completion 2028-06-14 (estimated)
Updated on ClinicalTrials.gov 2026-07-06