CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease

NARecruitingINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

September 30, 2027

Study Completion Date

December 31, 2027

Conditions
Relapsed/Refractory Autoimmune Diseases
Interventions
DRUG

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"

Trial Locations (1)

110001

RECRUITING

No. 155, The First Affiliated Hospital of China Medical University, Nanjing North Street, Heping District, Shenyang, Liaoning Province, Shenyang

All Listed Sponsors
collaborator

First Affiliated Hospital of China Medical University

UNKNOWN

lead

ShenZhen Cell Valley

INDUSTRY

NCT07193667 - CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease | Biotech Hunter | Biotech Hunter