Lupus nephritis is a serious kidney complication of systemic lupus erythematosus (SLE) in which the immune system attacks the kidneys, causing inflammation, protein loss in urine, and potentially kidney failure. It affects up to half of SLE patients and is a leading cause of long-term kidney damage and end-stage renal disease in younger women.
What's actually going on in research
Standard treatment with mycophenolate mofetil and hydroxychloroquine has been augmented by two approvals: voclosporin and belimumab are now approved as add-ons to standard care after trials demonstrated improved complete renal response rates. Trials are testing additional biologic agents targeting type I interferon, B cell pathways, and complement, as well as CAR-T cell therapy for refractory lupus nephritis.
Add-on biologic therapy
Voclosporin and belimumab are now approved as additions to standard immunosuppression; trials continue to refine who benefits most and whether combining these agents adds further benefit.
Type I interferon blockade
Anifrolumab, a monoclonal antibody blocking the type I interferon receptor, is approved for broader SLE and is being studied specifically for lupus nephritis, targeting a key driver of kidney inflammation.
CAR-T for refractory disease
Early-phase trials are testing CD19-targeted CAR-T cell therapy in patients with severe treatment-resistant lupus nephritis, following dramatic responses seen in small series of refractory SLE cases.
What to know before you search
Eligibility depends on kidney biopsy class, level of proteinuria, creatinine, prior immunosuppression, and current disease activity scores.
What types of trials are currently open
- Biologic add-on trials — Testing voclosporin, belimumab, and newer agents added to standard immunosuppression for improved renal outcomes.
- Interferon pathway trials — Evaluating anifrolumab and other type I interferon blockers specifically in lupus nephritis.
- CAR-T trials — Early-phase studies of CD19-targeted CAR-T therapy in patients with severe refractory disease.
- Maintenance therapy trials — Studying the optimal duration and tapering strategy for immunosuppression after achieving remission.
- Biomarker trials — Identifying urine and blood markers that predict flares and guide treatment decisions.
Recently added LUPUS Nephritis trials
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.
Allogeneic CD19/BCMA CAR-T for B Cell-Related Autoimmune Disease
This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C. QT-219C is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard "3+3" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219C .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .
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