Actively Recruiting
Autologous CD19 Car T-Cell Therapy For Severe Refractory Systemic Lupus Erythematosus (SLE)
Led by National University of Malaysia · Updated on 2025-05-29
5
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
Sponsors
N
National University of Malaysia
Lead Sponsor
P
Plutonet Sdn Bhd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This pilot clinical study aims to evaluate the effectiveness of Chimeric Antigen Receptor (CAR) T-cell therapy in treating severe, refractory systemic lupus erythematosus (SLE), an autoimmune disease driven by autoreactive B-cells. Current treatments for severe SLE, including glucocorticoids, cytotoxic, and immunosuppressive drugs, have significant limitations. These treatments do not adequately control the underlying autoimmune process and require long-term use, leading to chronic side effects and often failing to prevent permanent organ damage. Given the high prevalence and mortality rates associated with SLE in regions like Asia and Malaysia, there is a pressing need for more effective therapies.
CONDITIONS
Official Title
Autologous CD19 Car T-Cell Therapy For Severe Refractory Systemic Lupus Erythematosus (SLE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 to 65 years
- Clinical diagnosis of SLE according to the 2019 EULAR/ACR classification criteria
- Positive anti-nuclear antibody (ANA) with titer ≥1:80, anti-dsDNA ≥30 IU/mL by ELISA, or anti-Smith antibody
- Active disease not in remission or low disease activity state with at least one active organ system involvement
- Persistent active disease despite glucocorticoids and at least two of the following treatments for at least 3 months each: cyclophosphamide, mycophenolate mofetil or derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin
- Serum ALT less than 5 times normal, serum bilirubin less than 3 times normal
- Left ventricular ejection fraction greater than 45%
- Life expectancy greater than 3 months
- ECOG performance status 0 to 2
- Female participants of childbearing age must have a negative pregnancy test and use two effective contraception methods
- Male participants must use two effective contraception methods
You will not qualify if you...
- Active cancer or receiving cancer treatment
- Severe lung disease with FVC less than 45% or DLCO less than 30% predicted
- Severe heart disease including NYHA class III/IV, arrhythmia, AV block, or uncontrolled hypertension
- Liver failure or severe neurologic disorders
- Pre-existing irreversible kidney damage with creatinine clearance below 30 ml/min
- Severe pancytopenia
- HIV positive
- Active Hepatitis B or C infection
- Septicemia
- Pregnant or nursing female
- Receiving stem cell transplant within 12 weeks or chemotherapy/radiotherapy within 8 weeks of enrollment
- Active central nervous system involvement
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Kebangsaan Malaysia Medical Center
Bandar Tun Razak, Kuala Lumpur, Malaysia, 56000
Actively Recruiting
Research Team
S
S Fadilah Abdul Wahid, PhD
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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