NCT07328581

BCMA-CD19 cCAR T for the Treatment of Refractory Lupus

Phase I, IIa, Single-Arm, Study of BCMA-CD19-IL-15/IL15sushi cCAR T for the Treatment of Refractory Systemic Lupus Erythematosus, With or Without Lupus Nephritis

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: iCell Gene Therapeutics · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19-IL-15/IL15sushi cCAR T cells in patients with relapsed and/or refractory SLE, with or without Lupus Nephritis.

Detailed description

Systemic Lupus Erythematosus (SLE) is a multisystem, chronic autoimmune disease that may impact multiple organs including the joints, skin, kidney, heart, brain and lungs, with severity ranging from mild to life-threatening. Lupus Nephritis (LN) is the most prevalent and severe form of SLE with high morbidity and mortality and persistent relapses despite current therapies. SLE, with or without LN is driven largely by pathogenic autoantibodies produced by CD19 expressing B cells and BCMA expressing plasma cells, including long-lived plasma cells. ICG318, the investigational agent in this clinical trial is an armored, compound chimeric antigen receptor (CAR) composed of two independently functioning CARs that simultaneously target the B-cell CD19 surface antigen and the plasma cell/ long lived plasma cell BCMA surface antigen. This study is being conducted to evaluate the safety and efficacy of ICG318 in SLE patients with or without LN, who have not shown adequate clinical response to prior therapies. A single dose of ICG318 following a cyclophosphamide-only lymphodepletion regimen will be evaluated.

Conditions

• Systemic Lupus Erythematosus (SLE)
• Lupus Nephritis (LN)

Interventions

Type	Name	Description
BIOLOGICAL	ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following cyclophosphamide-only lymphodepletion	Anti-BCMA, Anti-CD19 Compound CAR-T Cells

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2026-01-09
• Last updated: 2026-01-09

Regulatory

• FDA-regulated drug study