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.
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.
Roche announced that Gazyva/Gazyvaro met its primary endpoint in the Phase III MAJESTY study for primary membranous nephropathy, showing statistically significant complete remission rates versus tacrolimus. The drug could become the first approved therapy for this rare autoimmune kidney disease.
Genentech's Phase III MAJESTY study showed Gazyva achieved statistically significant complete remission rates versus tacrolimus in primary membranous nephropathy, a chronic autoimmune kidney disease affecting over 96,000 people in the U.S.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| 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 |
NOT_YET_RECRUITING | PHASE2 |
| NCT07523542 |
SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus |
RECRUITING | PHASE1/PHASE2 |
| NCT07517536 |
CHT105 for the Treatment of Refractory Lupus Nephritis |
NOT_YET_RECRUITING | NA |
| NCT07505576 |
Anti-alpha-actinin Antibodies and Lupus Nephritis Activity |
NOT_YET_RECRUITING | |
| NCT07493655 |
Therapeutic Drug Monitoring of Mycophenolate Mofetil in Lupus Nephritis |
NOT_YET_RECRUITING | NA |
| NCT07393451 |
A Multicenter Phase 2a Clinical Study to Evaluate SIM0278 in Subjects With Active Lupus Nephritis |
NOT_YET_RECRUITING | PHASE2 |
| NCT07364396 |
Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07225387 |
Safety and Efficacy of Combination Belimumab and Voclosporin in the Treatment of Proliferative Forms of Lupus Glomerulopathy: Synergy Trial |
RECRUITING | PHASE4 |
| NCT07109986 |
UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis |
RECRUITING | PHASE1 |
