A Clinical Trial of CK0801 (a New Drug) In Patients With Treatment-Resistant Guillain-Barré Synd… (NCT03773328) | Clinical Trial Compass
WithdrawnPhase 1
A Clinical Trial of CK0801 (a New Drug) In Patients With Treatment-Resistant Guillain-Barré Syndrome (GBS)
Stopped: Pending contract negotiations
0Started 2022-11
Plain-language 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). 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Subject has received immunotherapy, chemotherapy, biologic or investigational agent within 4 weeks prior to CK0801 infusion.
What they're measuring
1
Number of Participants with Severe Infusion Toxicity as Assessed by CTCAE v4.0
Timeframe: 24 hours post-intervention
2
Number of Participants with Regimen Related Death
Timeframe: 30 days post-intervention
3
Number of Participants with Severe Cytokine Release Syndrome (CRS)
✕. 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.