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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • BRL-301

    Biological/Vaccine

    Single dose of Allogeneic Anti-CD19 CAR T cells will be infused

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: BRL-301Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The safety of BRL-301 in refractory systemic lupus erythematosus

Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs as assessed by CTCAE v5.0.

Time frame
3 months

Secondary outcomes

1

The efficiency of BRL-301 in refractory systemic lupus erythematosus

Number of patients with SRI-4 response: including SELENA-SLEDAI ≥4-Point improvement, BILAG 2004 with No new A domain score AND no more than 1 new B domain scores, PGA with No worsening (\<0.3-point increase)

Time frame
3 months
2

Cellular kinetics

CAR transgene levels by quantitative polymerase chain reaction (qPCR) in peripheral blood

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bioray Laboratories

Lead sponsor

First Affiliated Hospital of Zhejiang University

Collaborator

Source ClinicalTrials.gov
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