Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs (NCT05423691) | Clinical Trial Compass
RecruitingPhase 1
Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs
United States24 participantsStarted 2022-12-27
Plain-language summary
To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib
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.
Inclusion criteria
. Ability to comprehend and willingness to sign a written informed consent form (ICF) for the study.
. Age above 18 years inclusive at the time of signing the ICF.
. Participants who fulfill the diagnostic criteria of myelofibrosis including primary myelofibrosis and myelofibrosis arising from polycythemia vera and essential thrombocythemia
. Life expectancy is greater than 6 months.
. Subject has been receiving ruxolitinib therapy, is unlikely to benefit from further ruxolitinib monotherapy in the opinion of the investigator; AND meeting the following criteria: receiving ruxolitinib \>3 months prior to enrollment; AND stable dose for 8 weeks before starting therapy with CK0804
. Subject with evidence of evaluable residual burden of disease following ruxolitinib monotherapy treatment, consisting of:
. Willingness to avoid pregnancy or fathering children based on the criteria below
. ECOG performance status of 0 to 2
Exclusion criteria
. Any major surgery within 28 days before the first dose of study treatment.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
To determine Treatment limiting toxicity (TLT) as defined below
. Undergone any prior allogenic or autologous stem cell transplantation or a candidate for such transplantation.
. Received chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylating agent to treat the participant's disease, with the exception of ruxolitinib, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
. Participant has received splenic irradiation within the past 6 months.
. Significant concurrent, uncontrolled medical condition or infections, which in the opinion of the principal investigator may interfere in the study participation.
. Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
. Women who are pregnant or breastfeeding.
. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.