Actively Recruiting
Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE
Led by Chongqing Precision Biotech Co., Ltd · Updated on 2025-12-22
12
Participants Needed
2
Research Sites
139 weeks
Total Duration
On this page
Sponsors
C
Chongqing Precision Biotech Co., Ltd
Lead Sponsor
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the efficacy of MC-1-50 cell preparation in patients with refractory SLE, and to explore the applicable dose regimen for phase II clinical trials.
CONDITIONS
Official Title
Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or guardian consents to participate and understands the study
- Age 18 years or older, any gender
- Diagnosed with SLE by 2019 EULAR/ACR criteria
- Treated with hydroxychloroquine, glucocorticoids (≥1mg/kg/d prednisone or equivalent), immunosuppressants, and at least one approved biological agent for 3 months or more, with active disease or intolerance to conventional therapy
- SLEDAI-2K score ≥7 points
- Positive autoantibody test: ANA and/or anti-DSDNA
- Adequate organ function: cardiac (LVEF ≥50%), renal (creatinine ≤2.0× ULN or clearance ≥60ml/min), hepatic (ALT and AST ≤3× ULN), total bilirubin ≤2× ULN (or ≤3× for Gilbert syndrome), pulmonary (oxygen saturation ≥92% without oxygen)
- No serious mental disorders
- Eligible for apheresis or blood collection without contraindications
- Women of childbearing age must have a negative pregnancy test and agree to use effective contraception for one year after infusion
You will not qualify if you...
- Severe active central nervous system lupus requiring treatment at screening
- Acute severe nephritis or recent renal replacement therapy within 3 months
- Uncontrolled lupus crises at screening
- Previous CAR-T or gene-modified cell therapy
- Coexisting autoimmune diseases needing systemic treatment
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with abnormal viral loads
- Certain heart diseases including NYHA class III/IV heart failure, recent myocardial infarction or heart surgery, ventricular arrhythmias, or severe cardiomyopathy
- Uncontrolled infections within 1 week before enrollment
- History of solid organ or stem cell transplantation
- Stroke or seizure within 6 months
- Recent deep vein or artery embolism within 6 months
- History of malignant tumors except certain treated and inactive cancers
- Live vaccine within 4 weeks before screening
- Participation in other clinical trials within 1 month or 5 drug half-lives
- Pregnant or breastfeeding women, or plans to have children within 1 year after treatment
- Other conditions the investigator considers unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
Actively Recruiting
2
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
J
Jing Xue, M.D.
CONTACT
Z
Zhu Chen, M.D.
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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