For Healthcare Professionals

A Clinical Trial of CK0801 (a New Drug) In Patients With Treatment-Resistant Guillain-Barré Syndrome (GBS)

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About the study

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). Researchers also want to determine the highest possible dose that is safe to be given and to learn if CK0801 may improve the symptoms of GBS. There will be three doses of CK0801 given during this study. A minimum of three patients will be treated in each dose level. The dose a patient receives is dependent on the timing of when they enter the study, as after each dose level is completed the following patients will receive the next highest dose level.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Subject fulfills the diagnostic criteria for Guillain-Barré syndrome (GBS) (Appendix 1).
  2. HLA matched (≥ 3/6 at HLA-A, HLA-B, and HLA-DRB1) cord blood unit available for CK0801 generation.
  3. Subjects age 18 to 70 years.
  4. Subject has GBS disability scale score of 4 and unchanged 1 week after IVIG or PE treatment (Appendix 2).
  5. Subject has completed IVIG/PE treatment ≥ 4 weeks prior to CK0801 infusion.
  6. 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).
  7. Bilirubin ≤ 2 x ULN and, ALT ≤ 2 x ULN (unless Gilbert's syndrome).
  8. Calculated creatinine clearance of > 50mL/min using the Cockroft-Gault equation for adult patients 18
  9. 70 years old.
  10. 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).
  11. Subject has agreed to abide by all protocol required procedures including study-related assessments, visits and long term follow up.
  12. 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 CRITERIA

  1. Subject has received immunotherapy, chemotherapy, biologic or investigational agent within 4 weeks prior to CK0801 infusion.
  2. Subject has received prior CB Treg therapy.
  3. Subject has uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
  4. Subject has received a vaccination with a Live virus (e.g., Measles, Mumps, Rubella, Varicella).
  5. Subject is pregnant or breastfeeding.
  6. HIV seropositivity
  7. Subjects who are unable to provide consent or who, in the opinion of the Investigator will be unlikely to fully comply with protocol requirements.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 800-217-8247Email iconEmail Study Center

Study’s details


Contition

Guillain-Barré Syndrome

Age

18+

Phase

Phase 1

Participants needed

18

Est. Completion Date

Feb 2027

Treatment type

Interventional


Sponsor

Cellenkos, Inc.

ClinicalTrials.gov identifier

NCT03773328

Study number

CK0801-201-1

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