NCT07517536

CHT105 for the Treatment of Refractory Lupus Nephritis

A Clinical Study to Evaluate the Safety and Efficacy of CHT105, an Allogeneic CAR-T Cell Injection Targeting CD19 and CD70, in Patients With Refractory Lupus Nephritis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Systemic lupus erythematosus (SLE) is the most common systemic autoimmune disease in China. The kidneys are the organ most frequently affected in SLE and a major cause of mortality among SLE patients. Currently, cell-based therapy has emerged as an innovative treatment approach for SLE. CHT105 injection is an allogeneic chimeric antigen receptor T (CAR-T) cell product derived from healthy donors' T cells, which are transduced with a lentiviral vector encoding an anti-CD19/CD70 CAR. This engineered T-cell product effectively recognizes and eliminates immune cells expressing CD19 and/or CD70 antigens-including autoreactive T and B cells-and holds promise as a novel therapeutic option for patients with refractory lupus nephritis (LN). This study is a clinical trial evaluating the safety and preliminary efficacy of CHT105 injection-a CD19/CD70-targeting allogeneic CAR-T cell product-in adult patients with relapsed or refractory LN. Eligible participants will first undergo lymphodepleting preconditioning. Following confirmation of eligibility per standard infusion criteria, participants will receive a single intravenous infusion of CHT105 on Day 0 (D0). After CHT105 infusion, participants will undergo a 52-week short-term follow-up and up to a 15-year long-term follow-up.

Conditions

• Systemic Lupus Erythematosus
• Lupus Nephritis

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19/70 CAR T cells (CHT105)	All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by CHT105 infusion.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

1 site across 1 country: China