Actively Recruiting
Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs
Led by Cellenkos, Inc. · Updated on 2025-04-13
24
Participants Needed
4
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To assess the safety and tolerability of CK0804 as add-on therapy in participants with myelofibrosis, with suboptimal response to ruxolitinib
CONDITIONS
Official Title
Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to sign informed consent
- Age 18 years or older at consent
- Diagnosed with myelofibrosis including primary, post-polycythemia vera, or post-essential thrombocythemia
- Life expectancy greater than 6 months
- Receiving ruxolitinib therapy for more than 3 months and stable dose for at least 8 weeks
- Evidence of residual disease after ruxolitinib, including anemia, thrombocytopenia, neutropenia, symptoms scoring 10 points or more, or splenomegaly at least 5 cm below costal margin
- Willing to avoid pregnancy or fathering children during the study and follow contraceptive guidelines
- ECOG performance status 0 to 2
You will not qualify if you...
- Major surgery within 28 days before first study dose
- Prior allogeneic or autologous stem cell transplant or candidate for transplant
- Treatment with chemotherapy, immunomodulatory, immunosuppressive, biological, endocrine, targeted, antibody, or hypomethylating agents within 5 half-lives or 28 days before first dose, except ruxolitinib
- Splenic irradiation within past 6 months
- Significant uncontrolled medical condition or infection
- Unable or unlikely to comply with study treatment or evaluations
- Pregnant or breastfeeding women
- Any condition interfering with full participation or posing risk
- Laboratory values: platelets <50 x 10^9/L without assistance, ANC <0.5 x 10^9/L, ALT or AST ≥2.5 x ULN, direct bilirubin >2 x ULN, ALP ≥3 x ULN, creatinine clearance <50 mL/min
- Unwillingness to receive blood transfusions
- Unable or unwilling to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
UC Davis Health
Sacramento, California, United States, 95817
Actively Recruiting
2
Columbia University
New York, New York, United States, 10032
Not Yet Recruiting
3
Montefiore Einstein Cancer Center
The Bronx, New York, United States, 10461
Actively Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
T
Tara Sadeghi
CONTACT
S
Stacy Minor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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