Systemic lupus erythematosus has long lacked targeted treatments, but the field is moving fast — anifrolumab (a type-I interferon blocker) is approved, voclosporin is approved for lupus nephritis, and CAR-T cell therapy used for lymphoma is showing remarkable, sometimes drug-free remissions in early lupus trials.
What's actually going on in research
Trials are testing CAR-T cell therapy that resets the immune system, new biologics targeting B cells and interferon pathways, treatments for lupus nephritis, and approaches for cutaneous (skin) lupus. Researchers are also studying disparities in lupus outcomes, pregnancy planning with lupus, and biomarkers to guide treatment.
CAR-T for autoimmunity
Single CAR-T infusions have produced sustained, drug-free remissions in lupus in early trials. Larger studies are now underway in lupus and other autoimmune diseases.
Targeted biologics
Anifrolumab blocks type-I interferon, a key driver of lupus, and is reducing disease activity in trials. New B-cell and interferon-targeted drugs are also being tested.
Lupus nephritis
Kidney involvement is one of the most serious complications. Voclosporin and belimumab combinations are improving response rates in trials.
What to know before you search
Eligibility often depends on disease activity, organ involvement (especially kidney, skin, joints), antibody status, and prior medications tried.
What types of trials are currently open
- Treatment trials — Testing new biologics, pills, or cell therapies in people with lupus to reduce flares and organ damage.
- Cell therapy trials — Studies of CAR-T and related therapies aimed at resetting the immune system in lupus.
- Lupus nephritis trials — Testing treatments specifically for kidney involvement in lupus.
- Therapy strategy trials — Testing combinations of medications to reach remission and reduce steroid use.
- Observational studies — Following people with lupus to understand flares, pregnancy outcomes, and long-term organ damage.
Recently added LUPUS trials
Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA-UCAR-T cells in patients with autoimmune diseases. 36-72 patients are planned to be enrolled in the dose-escalation trial.
SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus
study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA. Participants undergo centralized screening immunophenotyping to determine whether their disease appears B-cell-dominant (CD19-preferred) or plasma-cell-dominant (BCMA-preferred), followed by leukapheresis, lymphodepletion, and a single CAR-T infusion. The main goals are to assess safety, determine a recommended Phase 2 dose within each arm, and estimate remission rates by Week 24.
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