3
Participants
Start Date
October 31, 2025
Primary Completion Date
September 30, 2027
Study Completion Date
December 31, 2027
CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases
"This is a prospective, single-center, open, single-arm, dose-escalation clinical trial to evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed/refractory autoimmune diseases. Intravenous infusion will be used, and the trial procedure will be divided as follows:~1. Screening period (D-28 to D-6):~ After subjects voluntarily sign an informed consent form, a screening period will be conducted to determine whether subjects are eligible for the trial based on inclusion and exclusion criteria.~2. Lymphocyte depletion pretreatment (Study D-5 to Study D-3):~ Subjects will be pre-treated with Lymphocyte depletion starting 5 days prior to CAR-T cell infusion (FC regimen)~3. Rest and Observation (Study D-2 to Study D-1):~ Follow the study procedures and perform the relevant examinations during the rest and observation period.~4. Cell Infusion and Primary Study Endpoint Observation Period (Study D0 to W12 post-infusion):Subjects will undergo CAR-T cell infusion at 2-da"
RECRUITING
No. 155, The First Affiliated Hospital of China Medical University, Nanjing North Street, Heping District, Shenyang, Liaoning Province, Shenyang
First Affiliated Hospital of China Medical University
UNKNOWN
ShenZhen Cell Valley
INDUSTRY