Actively Recruiting
Universal CAR-T Cells (BRL-301) in Refractory Systemic Lupus Erythematosus
Led by Bioray Laboratories · Updated on 2024-09-27
12
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
Sponsors
B
Bioray Laboratories
Lead Sponsor
F
First Affiliated Hospital of Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the refractory systemic lupus erythematosus.
CONDITIONS
Official Title
Universal CAR-T Cells (BRL-301) in Refractory Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years, any gender
- Diagnosed with systemic lupus erythematosus (SLE) per 2019 EULAR/ACR criteria with ANA ≥ 1:80 or positive anti-dsDNA/anti-Sm antibodies
- Active disease after failure or relapse following conventional treatment with at least two drugs including corticosteroids and immunomodulators for over 6 months
- At least one BILAG2004 Class A or two Class B scores
- SELENA-SLEDAI score of 8 or higher
- Positive CD19 expression on peripheral blood B cells by flow cytometry
- Sufficient bone marrow, liver, renal, coagulation, and cardiac function as specified
- Women of childbearing potential and their male partners agree to contraception or abstinence for 6 months post-infusion; women must have negative pregnancy test and not be breastfeeding
- Willing to participate, sign informed consent, and comply with follow-up
You will not qualify if you...
- History of serious drug allergy or allergic constitution
- Uncontrolled or suspected fungal, bacterial, viral, or other infections needing intravenous treatment
- Active central nervous system disease caused by SLE or other causes
- Serious heart diseases such as angina, myocardial infarction, heart failure, or arrhythmia
- Congenital immunoglobulin deficiency
- Other malignancies except certain non-melanoma skin cancers and specific cancers in remission over 5 years
- End-stage renal failure
- Recent use of high-dose corticosteroids or other clinical study drugs for SLE within specified timeframes
- Previous anti-CD20 monoclonal antibody or CAR-T/genetically modified T cell therapy within specified timeframes
- Positive for hepatitis B, hepatitis C, HIV, or syphilis infections
- Mental illness or severe cognitive impairment
- Participation in other clinical trials within 3 months prior to enrollment
- Pregnant or intending to conceive
- Deemed unsuitable by investigator for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
H
Hongyan Tong, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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