Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing Precision Biotech Co., Ltd

About this trial

This is a single arm study to evaluate the efficacy and safety of CD19 targeted CAR-T cells therapy for patients with Refractory Autoimmune Disease

Eligibility criteria

Qualifiers

≥18 years old, male or female;

Systemic Lupus Erythematosus (SLE), EULAR/ACR 2019 standard;

Sjogren's Syndrome (SS), 2016 ACR/EULAR standard;

Systemic Scleroderma (SSc), 2013 ACR/EULAR Standards;

Disqualifiers

Had previously received CAR T cell therapy;

patients with serious heart, liver, lung, blood system, endocrine system diseases, and the risk of participating in the trial is higher than the benefit judged by the researcher;

There is an active or uncontrollable infection that requires systemic treatment within 1 week prior to screening;

have previously received hematopoietic stem cell transplantation or solid organ transplantation (except corneal and hair transplantation), or have grade 2 or higher acute graft-versus-host disease (GVHD) within 2 weeks prior to screening;

Trial design

Treatments tested in this trial

  • CD19 targeted CAR-T cells

Treatment groups

24 Participants
are divided into 1 treatment group