drugset / Trial / NCT03773328

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

NCT03773328 ↗

Phase 1 Withdrawn Cellenkos, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-11
Primary completion
2025-02
Completion
2027-02

Outcome

Outcome not reported

Stopped: “Pending contract negotiations”

Drugs

EvaluationDrugModalityDoseRoute
Subject CK0801 Cell therapy 1e+06 cells/kg Intravenous
Subject CK0801 Cell therapy 3e+06 cells/kg Intravenous
Subject CK0801 Cell therapy 1e+07 cells/kg Intravenous