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New treatment option for Myelofibrosis
Official title Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs
ClinicalTrials.gov ID: NCT05423691
What this study is testing
What is CK0804?
CK0804 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myelofibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- Any major surgery within 28 days before the first dose of study treatment.
- 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...
- 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...
- Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
See the full eligibility 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...
- Subject with evidence of evaluable residual burden of disease following ruxolitinib monotherapy treatment, consisting of:
- presence of grade ≥2 anemia or thrombocytopenia or neutropenia, OR
- presence of disease-related symptoms, as determined by a Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN SAF TSS) score of ≥10 points, OR
- documented splenomegaly of at least 5 cm below the costal margin as measured by physical examination or splenomegaly as documented by ultrasound or MRI.
- Willingness to avoid pregnancy or fathering children based on the criteria below
- Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through 90 days after the last study treatment dose and must refrain from donating sperm during...
- Women of childbearing potential must have a negative serum pregnancy test at screening before the first dose (within 3 days of the first study treatment dose) and must agree to take appropriate precautions to avoid...
- Women of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible.
- ECOG performance status of 0 to 2
- Any major surgery within 28 days before the first dose of study treatment.
- 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...
- 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...
- Participants with laboratory values at screening as defined
- Platelets \< 50 × 10\^9/L without the assistance of growth factors, thrombopoietic factors, or platelet transfusions
- ANC \< 0.5 × 10\^9/L
- ALT ≥ 2.5 × ULN
- AST ≥ 2.5 × ULN
- Direct Bilirubin \> 2.0 × ULN
- ALP ≥ 3 × ULN
- Creatinine clearance \< 50 mL/min according to Cockcroft-Gault formula.
- Unwillingness to be transfused with blood components including RBC and platelet transfusions.
- Inability of the participant (or parent, guardian, or legally authorized representative) to comprehend the ICF or unwillingness to sign the ICF.
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- New York, New York, United States
- The Bronx, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; New York, New York, United States; The Bronx, New York, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.