A Clinical Trial of CK0801 (a New Drug) in Patients With Bone Marrow Failure Syndrome (BMF)
Condition(s) studied
Investigational drug(s) / intervention(s)
CK0801: CK0801 (a Cord blood-derived T-regulatory cell product)
Study 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.
Eligibility
Primary outcome measure(s)
- Number of Participants with Severe Infusion Toxicity as Assessed by CTCAE v4.0 — 24 hours post-intervention
Number of Participants with Severe (Grade 3 or 4) Toxicity - Number of Participants with Regimen Related Death — 30 days post-intervention
Number of Participants with Regimen Related Death - Number of Participants with Severe Cytokine Release Syndrome (CRS) — 30 days post-intervention
Number of Participants with Severe (Grade 3 or 4) CRS
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Sarcoma Oncology Research Center, Cancer Center of Southern California | Santa Monica | California | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas |
More Cellenkos, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03773393 on ClinicalTrials.gov ↗ ← All trials in the USA