Using CAR T-cell therapy to treat severe lupus
Autologous CD19 Car T-Cell Therapy For Patients With Severe Refractory Systemic Lupus Erythematosus - A Pilot Study
This study is testing a new CAR T-cell therapy to see if it can help people with severe lupus who haven't found relief from other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | National University of Malaysia Academic / other |
| Drugs / interventions | belimumab, anifrolumab, rituximab, obinutuzumab, chemotherapy, methotrexate, cyclophosphamide, Chimeric Antigen Receptor, CAR-T, CAR T |
| Locations | 1 site (Bandar Tun Razak, Kuala Lumpur) |
| Trial ID | NCT06710717 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with severe, treatment-refractory systemic lupus erythematosus.
Not a fit: Patients with mild or well-controlled lupus, or those who have not exhausted standard treatment options, may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new, effective treatment option for patients suffering from severe lupus who have not responded to conventional therapies.
How similar studies have performed: While CAR T-cell therapy has shown promise in other autoimmune conditions, this specific application for severe SLE is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- 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: \- 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 this trial is running
Bandar Tun Razak, Kuala Lumpur
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.