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Cell Therapy

CK0801 for Bone Marrow Disease

Phase 1
Waitlist Available
Led By Tapan M Kadia, MD
Research Sponsored by Cellenkos, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post-intervention
Awards & highlights

Study Summary

This trial seeks to find if CK0801 is safe and effective for patients with bone marrow failure syndrome.

Who is the study for?
Adults diagnosed with bone marrow failure syndrome, including aplastic anemia, myelodysplastic syndrome, or myelofibrosis, who can't be treated with standard therapy or haven't responded to it. They must have a matched cord blood unit for the treatment and their liver and kidney functions should meet specific criteria. Women of childbearing potential must use effective birth control.Check my eligibility
What is being tested?
The trial is testing CK0801, a new cell-based therapy derived from cord blood to see if it's safe at high doses and if it helps improve symptoms of bone marrow failure. All participants will receive this experimental treatment after failing or being unable to undergo standard therapies.See study design
What are the potential side effects?
As CK0801 is a new drug under investigation, side effects are not fully known yet but may include typical reactions related to immune cell infusions such as fever, chills, fatigue, headache, nausea or muscle pains.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Regimen Related Death
Number of Participants with Severe Cytokine Release Syndrome (CRS)
Number of Participants with Severe Infusion Toxicity as Assessed by CTCAE v4.0

Trial Design

1Treatment groups
Experimental Treatment
Group I: CK0801Experimental Treatment1 Intervention
All subjects will receive adoptive therapy with an infusion of unrelated cord blood-derived regulatory T cells: CK0801. Subjects will receive one intravenous dose of CK0801 (Treg cells) on study Day 0.

Find a Location

Who is running the clinical trial?

Cellenkos, Inc.Lead Sponsor
4 Previous Clinical Trials
135 Total Patients Enrolled
Tapan M Kadia, MDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center
1 Previous Clinical Trials
125 Total Patients Enrolled

Media Library

CK0801 (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03773393 — Phase 1
Bone Marrow Disease Research Study Groups: CK0801
Bone Marrow Disease Clinical Trial 2023: CK0801 Highlights & Side Effects. Trial Name: NCT03773393 — Phase 1
CK0801 (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03773393 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial of CK0801 (a New Drug) in Patients With Bone Marrow Failure Syndrome (BMF)
2019. "A Clinical Trial of CK0801 (a New Drug) in Patients With Bone Marrow Failure Syndrome (BMF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03773393.
~0 spots leftby May 2024
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