Status:
WITHDRAWN
A Clinical Trial of CK0801 (a New Drug) In Patients With Treatment-Resistant Guillain-Barré Syndrome (GBS)
Lead Sponsor:
Cellenkos, Inc.
Conditions:
Guillain-Barré Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The goal of this 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 Guillain-Barré Syndrome (GBS). Researc...
Detailed Description
CK0801 (Cord blood-derived T-regulatory cells) consists of ex vivo expanded T-regulatory cells with a flow cytometry phenotype of ≥ 60% CD4+CD25+ T-regulatory (Treg) cells and \< 10% CD4-CD8+ T-cytoto...
Eligibility Criteria
Inclusion
- Subject fulfills the diagnostic criteria for Guillain-Barré syndrome (GBS) (Appendix 1).
- HLA matched (≥ 3/6 at HLA-A, HLA-B, and HLA-DRB1) cord blood unit available for CK0801 generation.
- Subjects age 18 to 70 years.
- Subject has GBS disability scale score of 4 and unchanged 1 week after IVIG or PE treatment (Appendix 2).
- Subject has completed IVIG/PE treatment ≥ 4 weeks prior to CK0801 infusion.
- Subject has modified Erasmus GBS outcome score (mEGOS score) of ≥7 at the time of presentation and unchanged 1 week after IVIG or PE treatment (Table 3).
- Bilirubin ≤ 2 x ULN and, ALT ≤ 2 x ULN (unless Gilbert's syndrome).
- Calculated creatinine clearance of \> 50mL/min using the Cockroft-Gault equation for adult patients 18 - 70 years old.
- 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. If subject is temporarily unable to sign the consent due to disease-related complications (e.g., upper extremity paralysis), a legally authorized representative (LAR) will be used. The subject will sign the consent as soon as they are capable.
Exclusion
- Subject has received immunotherapy, chemotherapy, biologic or investigational agent within 4 weeks prior to CK0801 infusion.
- Subject has received prior CB Treg therapy.
- Subject has uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
- Subject has received a vaccination with a Live virus (e.g., Measles, Mumps, Rubella, Varicella).
- Subject is pregnant or breastfeeding.
- HIV seropositivity
- 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 :
November 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03773328
Start Date
November 1 2022
End Date
February 1 2027
Last Update
January 4 2023
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