Clinical Trial

A Clinical Trial of CK0801 (a New Drug) in Patients With Bone Marrow Failure Syndrome (BMF)

Active, Not Recruiting Phase 1
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Summary
The goal of this clinical research study is to determine whether it is safe and practical to give CK0801 (a Cord blood-derived T-regulatory cell product) to patients with bone marrow failure syndrome. Researchers want to determine the highest possible dose that is safe to be given. Researchers also want to learn if CK0801 may improve the symptoms of bone marrow failure syndrome. Patients enrolled in this study will all have been diagnosed with treatment refractory bone marrow failure syndrome (which includes aplastic anemia, myelodysplastic syndrome, or myelofibrosis). Participants eligible to participate in this study are unable or unwilling to be treated with standard therapy or have failed standard therapy.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2018-12-10; most recent amendment 2025-04-10.
Status change: Recruiting → Active, Not Recruiting 2021-06-21
Status change: Not Yet Recruiting → Recruiting 2019-06-03
Trial Details
NCT Number NCT03773393
Lead Sponsor Cellenkos, Inc.
Conditions Bone Marrow Disease
Enrollment 18 participants
Start Date 2019-05-30
Primary Completion 2027-05-25 (estimated)
Study Completion 2027-05-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-13