drugset / Trial / NCT06414135

Relmacabtagene Autoleucel for the Treatment of Systemic Sclerosis

NCT06414135

NaSingle-groupOpen-labelTreatment

Summary

Relma-cel is a product containing CD19-CAR-transduced T cells. The purpose of this study is to evaluate the safety of Relma-cel at different dose levels in patients with early diffuse systemic sclerosis. Efficacy will be explored too. If enrolled, participants will undergo leukapheresis, lymphodepleting chemotherapy and administration of Relma-cel.

Timeline

Start
2024-06-12
Primary completion
2025-05
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Relmacabtagene Autoleucel Cell therapy 2.5e+07 cells
Subject Relmacabtagene Autoleucel Cell therapy 5e+07 cells
Subject Relmacabtagene Autoleucel Cell therapy 7.5e+07 cells

Indications