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CK0804 for Myelofibrosis

This study is testing a new treatment called CK0804 for people with myelofibrosis, a type of bone marrow cancer. CK0804 is a special type of cell therapy (T-regulatory cell product) that is designed to go to the bone marrow. The goal is to see how safe CK0804 is when added to ruxolitinib, a common myelofibrosis medication, for patients who haven't fully responded to ruxolitinib alone. The study plans to enroll about 24 participants. To join, you must be over 18 and have myelofibrosis. The current status of the study is unclear.

Study design
This study is designed in two parts: a safety run-in phase followed by an expansion phase. It will involve approximately 24 participants.
What's involved
Participants will receive the CK0804 treatment, and safety will be checked for 28 days after the first infusion.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoint is measured at 28 days after the first infusion.

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NCT05423691

Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs

Recruiting
PHASE1Ages 18+InterventionalTreatment
Cellenkos, Inc.
~24 participants
Updated 2025-04-13 on ClinicalTrials.gov
What's tested:CK0804

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine Treatment limiting toxicity (TLT) as defined below
Measured over 28 days

Conditions

Myelofibrosis

Explore related trials

Myelofibrosis

Where it's being run

4 sites across 3 states
New York2
California1
Texas1

Who to contact

Tara Sadeghi
[email protected]
713-806-4787
Email the study team

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Eligibility criteria

Inclusion

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. 7. 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. 8. ECOG performance status of 0 to 2

Exclusion

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. 10. Unwillingness to be transfused with blood components including RBC and platelet transfusions. 11. Inability of the participant (or parent, guardian, or legally authorized representative) to comprehend the ICF or unwillingness to sign the ICF.

What this trial measures

  • To determine Treatment limiting toxicity (TLT) as defined below28 days

    * severe (grade 3 or 4) infusion-related toxicity within 24 hours (NCI-CTCAE V5.0) of exposure that does not resolve with standard of care treatment within 72 hours. * regimen related death within 28 days