Status:
RECRUITING
Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs
Lead Sponsor:
Cellenkos, Inc.
Conditions:
Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib
Detailed Description
1. Safety Run-in The study will employ a 3+3+3 design to assess the safety and tolerability of the treatment based on treatment-limiting toxicities (TLTs) occurring up to 1 Cycle (28 days) after t...
Eligibility Criteria
Inclusion
- 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:
- 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 this period. Permitted methods that are at least 99% effective in preventing should be communicated to the participants and their understanding confirmed.
- 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 pregnancy (with at least 99% certainty) from screening through the safety follow-up visit and must not donate oocytes during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed,
- 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
Exclusion
- 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 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.
- 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.
Key Trial Info
Start Date :
December 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05423691
Start Date
December 27 2022
End Date
December 30 2026
Last Update
April 13 2025
Active Locations (4)
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1
UC Davis Health
Sacramento, California, United States, 95817
2
Columbia University
New York, New York, United States, 10032
3
Montefiore Einstein Cancer Center
The Bronx, New York, United States, 10461
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030