Actively Recruiting
IM19 CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus (SLE)
Led by Peking University Third Hospital · Updated on 2025-08-17
6
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is a single-arm, open-label clinical trial intended to recruit 6 refractory SLE subjects who meet the inclusion and exclusion criteria. The subjects will receive IM19 CAR-T cell infusion therapy at a dose of 1×10\^6/kg or 1×10\^8 CAR-T cells . The primary endpoint is to evaluate the improvement in SLE disease activity (SLEDAI-2K) at 90 days and the occurrence of adverse events related to IM19 CAR-T cell infusion within 28 days post-infusion. Additionally, the long-term efficacy was evaluated, including the improvement of SLEDAI-2K score and achieving lupus low disease activity (LLDAS) at day 180 and day 360, and renal response at day 180 and day 360. The persistence and duration of IM19 CAR-T cells in the peripheral blood of subjects will also be evaluated. The study plan includes five phases: screening phase, cell collection phase, lymphodepletion pretreatment phase, cell infusion phase, and follow-up phase.
CONDITIONS
Official Title
IM19 CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus (SLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with systemic lupus erythematosus meeting 2019 EULAR/ACR criteria
- Age between 18 and 65 years old
- Weight at least 40 kg
- Refractory SLE with active or relapsing disease after standard treatments including steroids, immunosuppressants, and biologics
- Currently using stable doses of steroids (max 30mg/day prednisone or equivalent), antimalarials, or immunosuppressants with specified stability periods
- SLEDAI-2K disease activity score of 10 or above
- Women of childbearing age must have a negative pregnancy test and agree to effective contraception during the trial
- Male participants with fertile partners must agree to effective contraception during the trial
- Voluntary participation with signed informed consent
You will not qualify if you...
- Life-threatening conditions unsuitable for study participation
- History of alcohol or drug abuse within past 24 weeks
- History of malignant tumors other than B-cell lymphoma
- Major surgery within 24 weeks before screening or planned within 24 weeks after enrollment
- Overlapping connective tissue diseases affecting disease activity assessment
- Infection with HIV, selective IgA deficiency, T-cell deficiency virus, chronic hepatitis B or C, or SARS-CoV-2
- Active tuberculosis or bacterial infection
- Recent significant heart disease or events within 6 months prior to screening
- Recent symptomatic deep vein thrombosis or pulmonary embolism within 6 months
- Elevated liver enzymes or bilirubin excluding those caused by SLE hepatitis
- Stage 4 chronic kidney failure or significant hematological abnormalities at screening
- Treatment with CD20 monoclonal antibodies within past 6 months
- Any condition deemed unsuitable by researchers for trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Universitiy Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
J
Jinxia Zhao
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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