A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neopl… (NCT06150157) | Clinical Trial Compass
RecruitingPhase 1
A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms
United States, Canada, China220 participantsStarted 2023-12-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial for JNJ-88549968, meaning the main goal right now is to find a safe dose and identify side effects rather than prove it works — what does that mean for my personal risk compared to the potential benefit at this stage?
2The trial is specifically designed for people with CALR-mutated myeloproliferative neoplasms — has my mutation been confirmed as the type that would make this trial worth discussing as an option for my situation?
3One of the key things they're measuring is 'dose-limiting toxicity,' which means they're still figuring out how much of this drug is too much — how does that uncertainty compare to the side effect profile of standard treatments available to me right now?
4This trial has multiple parts, including US-only portions — do you know which part I might be considered for, and what the difference in visits, monitoring, or demands on my time would look like for each part?
5Before we consider this trial, is there a standard therapy or an already-approved treatment for CALR-mutated MPN that you'd recommend I try first, and how would going on this trial affect my ability to access those options later?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1, Part 1b (US Only): Number of Participants With Dose Limiting Toxicity (DLT)
Timeframe: Approximately up to 35 days after first dose of study treatment
2
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs)
Timeframe: Up to 2 years
3
Part 1, 2, Part 1b (US Only), Part 2b (US Only): Number of Participants with Adverse Events (AEs) by Severity