drugset / Trial / NCT02427776

A Trial for Evaluating Both Safety and Preliminary Efficacy of a Single Infusion of Stimulated Autologous CD4+T Cells in Patients With Relapsing- Remitting Multiple Sclerosis

NCT02427776 ↗

Phase 1/2 Terminated 2 enrolled Imcyse SA
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and the preliminary efficacy of a single infusion of stimulated autologous CD4+ T cells in patients with Relapsing-Remitting Multiple Sclerosis. The study duration for the patients (from start of baseline to end of follow-up) is 270 days.

Timeline

Start
2015-01
Primary completion
2016-08
Completion
2016-08

Outcome

Outcome not reported

Stopped (Enrollment): “study ended prior enrollment of the first patient because of unexpected issues in the manufacturing process prevented production of adequate clinical batches”

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous CD4+T cells Cell therapy 5e+06 cells —
Subject Autologous CD4+T cells Cell therapy 5e+07 cells —