Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT07161193
Brief Summary:
The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases
Detailed Description:
This is a single-center, open-label, single-arm, dose-escalation trial. In this study, we will recruit seven kinds of refractory autoimmune diseases including moderate-to-severe Systemic lupus erythematosus (SLE), refractory Pemphigus, refractory Idiopathic inflammatory myopathy (IIM), Systemic sclerosis (SSc), Refractory ANCA-Associated Vasculitis/Nephritis,refractory Rheumatoid arthritis(RA) and moderate-to-severe refractory Psoriasis.
Patients with Refractory Autoimmune Diseases will receive CD19 CAR T cells. The primary objective is to evaluate the safety and efficacy of CD19 CAR T cell therapy in subjects with Refractory Autoimmune Diseases and to determine the optimal biological dose (OBD) in phase I and to learn about the efficacy CD19 CAR T-cell therapy in patients with Refractory Autoimmune Diseases in phase II.
The primary endpoint is to evaluate the incidence and severity of cytokine release syndrome and severe neurotoxic adverse events within 28 days after CAR-T cell infusion.A total number of 3o subjects will be enrolled.
Study:
NCT07161193
Study Brief:
Protocol Section:
NCT07161193