Status:
ACTIVE_NOT_RECRUITING
A Clinical Trial of CK0801 (a New Drug) in Patients With Bone Marrow Failure Syndrome (BMF)
Lead Sponsor:
Cellenkos, Inc.
Conditions:
Bone Marrow Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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....
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...
Eligibility Criteria
Inclusion
- Subjects who fulfill the diagnostic criteria of bone marrow failure syndrome including: aplastic anemia, myelodysplastic syndrome, or myelofibrosis.
- HLA matched (≥ 3/6) cord blood unit available for CK0801 generation.
- Subjects age ≥ 18 years.
- Bilirubin ≤ 2 x ULN and SGPT (ALT) ≤ 2 x ULN (unless Gilbert's syndrome is documented).
- Calculated creatinine clearance of \> 50mL/min using the Cockcroft-Gault equation.
- Zubrod performance status ≤ 2.
- Female subjects of child bearing potential (FPCP) must have a negative urine or serum pregnancy test. NOTE: FPCP is defined as premenopausal and not surgically sterilized. FPCP must agree to use maximally effective birth control or to abstain from heterosexual activity throughout the study. Effective contraceptive methods include intra-uterine device, oral and/or injectable hormonal; contraception, or 2 adequate barrier methods (e.g., cervical cap with spermicide, diaphragm with spermicide).
- Subject has agreed to abide by all protocol required procedures including study-related assessments, visits and long term follow up.
- Subject is willing and able to provide written informed consent.
Exclusion
- Subject has received an investigational agent within 4 weeks prior to CK0801 infusion.
- Subject has received radiation or chemotherapy within 21 days prior to CK0801 infusion.
- Subject has received prior cord blood-derived T-regulatory therapy.
- HIV seropositivity.
- Subject has uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
- Subjects with uncontrolled inter-current illness that in the opinion of the investigator would place the patient at greater risk of severe toxicity and/or impair the activity of CK0801
- Subjects is pregnant or breastfeeding.
- Bone marrow failure caused by stem cell transplantation.
- Subjects who are unable to provide consent or who, in the opinion of the Investigator will be unlikely to fully comply with protocol requirements.
Key Trial Info
Start Date :
May 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03773393
Start Date
May 30 2019
End Date
May 30 2027
Last Update
April 13 2025
Active Locations (2)
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1
Sarcoma Oncology Research Center, Cancer Center of Southern California
Santa Monica, California, United States, 90403
2
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030