Universal CAR-T Cells (BRL-301) in Refractory Systemic Lupus Erythematosus
ConditionSystemic Lupus Erythematosus (SLE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBioray Laboratories
About this trial
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the refractory systemic lupus erythematosus.
Eligibility criteria
Qualifiers
Age range from 18 to 65 years old (including threshold), regardless of gender;
Subjects diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria; ANA ≥ 1:80, or positive for anti dsDNA and/or anti Sm antibodies;
The condition becomes active again after conventional treatment is ineffective or the disease relapses. Conventional treatment is defined as the use of two or more drugs, including corticosteroids (more than 1mg/kg/d) and any one or more of the following immunomodulatory drugs for over six months: antimalarial drugs, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biologics including rituximab, belimumab, etanercept, etc.
At least one BILAG2004 Class A or two Class B score, or both;
Disqualifiers
Have a serious history of Drug allergy or allergic constitution;
Fungi, bacteria, viruses, or other infections that are uncontrollable or require intravenous medication treatment exist or are suspected;
Active central nervous system disease caused by SLE or not (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system Vasculitis);
Individuals with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia;
Trial design
Treatments tested in this trial
- BRL-301
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Bioray Laboratories
Lead sponsor
First Affiliated Hospital of Zhejiang University
Collaborator
Source ClinicalTrials.gov