Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT03773393
Brief 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.
Detailed Description:
Primary Objective:
To determine dose-limiting toxicity of CK0801 as defined as any of the events each start at the time of CK00801 infusion
1. Severe (grade 3 or 4) infusion toxicity within 24 hours (NCI-CTCAE V4.0)
2. Regimen related death within 30 days
3. Severe (grade 3 or 4) Cytokine Release Syndrome within 30 days
Secondary Objective:
1. Preliminary assessment of disease-specific response
2. Duration of disease-specific response
Study:
NCT03773393
Study Brief:
Protocol Section:
NCT03773393