Using CAR T-cell therapy to treat severe lupus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot clinical study evaluates the effectiveness of autologous CD19 CAR T-cell therapy for patients with severe, treatment-refractory systemic lupus erythematosus (SLE). The study aims to assess the safety, tolerability, and efficacy of this innovative treatment approach, which targets autoreactive B-cells responsible for the autoimmune response in SLE. Conducted in Malaysia, the study will involve five patients diagnosed with severe SLE who have not responded adequately to existing therapies. The outcomes will be measured through clinical remission rates, serologic remission, and improvements in quality of life.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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Aged between ≥ 18 to ≤ 65 years Clinical Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria (Fanouriakis et al., 2019) Positive anti-nuclear antibody (ANA) (titer ≥1:80 ), anti-dsDNA (≥30 IU/mL on enzyme-linked immunosorbent assay \[ELISA\]), or anti-Smith at screening or by documented medical history Active disease (defined by not being in remission according to DORIS criteria or in a low disease activity state \[LLDAS\]) (Franklyn et al., 2016, van Vollenhoven et al., 2021) With at least one active organ system involvement Persistent active disease with insufficient response to glucocorticoids and at least 2 of the following treatments for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin.

Serum ALT \<5 times the normal value, serum bilirubin \<3 times the normal value, Left ventricular ejection fraction \>45% Life expectancy of more than 3 months Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Psychological, sociological or geographical conditions precluding compliance A female of childbearing age must have a negative pregnancy test and is on two effective contraception methods A male must use two effective contraception methods

Exclusion Criteria:

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Active cancer or receiving cancer treatment Evidence of severe lung, FVC \<45% and/or DLCO (corrected for Hb) \<30% predicted, heart (NYHA class III/IV, arrhythmia, AV block, uncontrolled hypertension), liver failure or severe neurologic disorders.

Pre-existing irreversible kidney damage and creatinine clearance below 30 ml/min ( to review) Severe pancytopenia HIV positivity. Active Hepatitis B, C infection. Septicemia. Pregnant/nursing female. Receiving stem cell transplant within 12 weeks of enrolment, chemotherapy or radiotherapy within 8 weeks of enrolment Active CNS involvement.

Where it's running

• University Kebangsaan Malaysia Medical Center
  Bandar Tun Razak, Kuala Lumpur, Malaysia Recruiting

Study contacts

• Study coordinator: S Fadilah Abdul Wahid, PhD
• Email: sfadilah@hctm.ukm.edu.my
• Phone: +60391456450

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.