CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 18 target
Drug / intervention
CK0801biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03773393
NCT03773393Phase 1ActiveOn TrackUpdated 14mo ago
CompareCT.gov

Phase I Trial to Evaluate the Safety and Feasibility of CK0801 in Treatment of Bone Marrow Failure Syndrome

Cellenkos, Inc.·interventional·Posted Dec 12, 2018·Updated Apr 13, 2025

In Brief

A Phase 1 clinical trial evaluating CK0801 for Bone Marrow Disease. Active but no longer recruiting, targeting 18 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Marrow Disease
CountriesUnited States
Collaborators--

Timeline

Phase 1Active
201920202021202220232024202520262027
First PostedDec 12, 2018
Enrollment StartMay 30, 2019
Primary CompletionMay 25, 2027
Study CompletionMay 30, 2027
TodayJul 1, 2026
Enrollment to primary: 8.0 yearsPosted 7.6 years agoPrimary completion in 11 months

Interventions

CK0801biological

CK0801 (a Cord blood-derived T-regulatory cell product)