Systemic lupus erythematosus (SLE) treatment has slowly expanded beyond hydroxychloroquine and corticosteroids with the approvals of belimumab and anifrolumab. Most importantly, anti-CD19 CAR-T cell therapy has produced remarkable responses in early trials of severe refractory SLE — potentially transformative for the field. For patients with lupus, particularly severe or refractory disease, clinical trials for lupus can offer access to investigational therapies including emerging cell therapies. This guide covers how to find lupus trials, active research areas, and resources.
Categories of lupus trials
Active lupus trials in 2026 include:
CAR-T cell therapy: Anti-CD19 CAR-T cells produced complete responses in initial small studies of refractory SLE. Multiple trials expanding access to this approach.
B-cell depleting therapies: Beyond rituximab and obinutuzumab, novel B-cell targeting approaches.
Type I interferon antagonists: Anifrolumab approved; other agents in development.
BLyS/BAFF inhibitors: Beyond belimumab, novel agents targeting B-cell activation.
Lupus nephritis specifically: Trials targeting kidney involvement which is a major cause of morbidity.
Treatment-resistant disease: Trials for patients who haven’t responded to multiple therapies.
Where to find lupus trials
Resources:
- ClinicalTrials.gov
- Lupus Research Alliance
- Lupus Foundation of America
- Major academic rheumatology programs
Typical eligibility for lupus trials
Common inclusion criteria:
- Confirmed SLE diagnosis meeting ACR or EULAR/ACR criteria
- Active disease (SLEDAI or BILAG scores in range)
- Specific organ involvement for organ-specific trials
- Inadequate response to standard therapy
Common exclusion criteria:
- Active infection
- Pregnancy
- Other autoimmune conditions (varies)
- Specific organ damage that would complicate the trial
Frequently Asked Questions
Is CAR-T therapy for lupus available?
Through clinical trials primarily. Initial results are remarkable but the approach involves significant short-term risks (cytokine release syndrome, neurotoxicity). Trials at major academic centers.
Are lupus nephritis trials separate?
Often yes. Lupus nephritis is studied with specific endpoints related to kidney function and proteinuria.
Can I participate if I’m on hydroxychloroquine?
Yes, hydroxychloroquine is generally allowed as background therapy and not required to be stopped.
Can I be in a lupus trial during pregnancy?
No. Pregnancy is excluded from most trials.
How long do lupus trials typically last?
Phase 3 trials are typically 52 weeks with longer-term extensions.
The bottom line on lupus trials
Lupus research has expanded with CAR-T cell therapy, novel B-cell approaches, and type I interferon antagonists. Lupus Research Alliance and academic rheumatology centers provide trial resources. Discuss with your rheumatologist for treatment planning, particularly for severe or refractory disease.