Lupus nephritis is kidney disease caused by systemic lupus erythematosus, in which autoimmune injury inflames and damages renal tissue. Disease progression can lead to chronic kidney impairment and, in severe cases, kidney failure requiring dialysis or transplant.
Phase I CARLYSLE trial data show CAR-T therapy obe-cel induces remission in severe refractory lupus with a favorable safety profile. Separate case report documents two successful pregnancies after dual-target CAR-T therapy with no transmission to infants.
A phase IIb trial demonstrated that low-dose IL-2 therapy produced dose-dependent improvements in SLE patients, with 69.7% achieving SRI-4 response at the highest dose versus 23.5% on placebo. A separate systematic review found IL-17 inhibitors remain potential SLE treatment options, though efficacy data are limited.
New AI tools predict diabetic kidney disease from retinal images, flag hemodialysis patients at hospitalization risk, and advance lupus nephritis care. Findings were presented at ARVO 2026 and published in NEJM Catalyst, The Lancet, and the International Journal of Molecular Sciences.
Autolus Therapeutics reported $74.3 million in 2025 revenue during its first commercial year, while facing a -265% gross margin. The company aims to achieve positive margins by 2026 through scaling production and expanding into autoimmune diseases with promising early lupus trial results. The broader CAR-T therapy market is projected to reach $9.85 billion in the US by 2033.
New research demonstrates machine learning can optimize drug dosing, identifies biomarkers of treatment response, and validates prognostic criteria for long-term kidney survival in pediatric lupus nephritis patients.
Obinutuzumab demonstrated superior efficacy in two separate phase 3 trials for systemic lupus erythematosus and primary membranous nephropathy, with statistically significant improvements in remission rates and disease response measures.
Phase 3 trials demonstrate atrasentan slows kidney function decline in IgA nephropathy patients, while obinutuzumab achieves superior remission rates in primary membranous nephropathy compared to standard treatment.
A 24-year-old woman with refractory lupus achieved two successful pregnancies following dual-target CAR-T cell therapy, while bispecific T cell engagers showed efficacy in treatment-refractory antisynthetase syndrome and systemic sclerosis patients.
The Phase III MAJESTY study met its primary endpoint, showing significantly more people achieved complete remission at two years with Gazyva versus tacrolimus. If approved, Gazyva would be the first therapy specifically indicated for primary membranous nephropathy.
Roche announced positive Phase III MAJESTY trial results showing Gazyva achieved significantly higher complete remission rates at two years versus tacrolimus in primary membranous nephropathy, with no new safety signals identified.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07780045 |
SII and SIRI as Prognostic Biomarkers in Lupus Nephritis |
NOT_YET_RECRUITING | |
| NCT07767188 |
A Prospective, Multicenter Trial to Explore the Efficacy and Safety of Obinutuzumab Adds on to Standard-of-care Therapy Consisting of Mycophenolate Mofetil (MMF) and Corticosteroids (O-triple) as Initial Therapy in the Active Lupus Nephritis Patients |
NOT_YET_RECRUITING | PHASE3 |
| NCT07760480 |
Assessing Residual Inflammation and Macrophage Presence in Lupus Nephritis After 3 Months of Intensified Treatment With Prednisolone, Mycofenolate Mofetil and Voclosporin as Compared to Mycofenolate Mofetil and Prednisolone |
RECRUITING | PHASE4 |
| NCT07721363 |
Obinutuzumab for Systemic Lupus Erythematosus Pure Membranous Nephropathy: a Phase II Trial |
NOT_YET_RECRUITING | PHASE2 |
| NCT07675291 |
Rituximab Combining With Low-Dose Mycophenolate Mofetil on Proliferative Lupus Nephritis in Children |
NOT_YET_RECRUITING | NA |
| NCT07666711 |
Biomarker Development for Autoimmune Disorders Involving the Kidneys |
RECRUITING | |
| NCT07611214 |
PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis |
RECRUITING | PHASE4 |
| NCT07598396 |
A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis |
RECRUITING | PHASE2 |
| NCT07570862 |
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis |
RECRUITING | PHASE2 |
| NCT07523542 |
SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus |
RECRUITING | PHASE1/PHASE2 |
