iCell Gene Therapeutics
This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single infusion of ICG318 in participants with refractory SLE, with or without LN. Participants will receive protocol-specified lymphodepletion followed by ICG318 at the recommended Phase 2 dose.
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 clin…
Key Inclusion Criteria: 1. Age 16-70 years at the time of signing the informed consent 2. Have a diagnosis of SLE by EULAR/ACR 2019 criteria for ≥6 months. 3. Have at least one of an antinuclear antibody, anti-double-stranded deoxyribonucleic acid (dsDNA), or elevated anti-Smith (Sm) antibody 4. Inadequate response to 2 prior standard of care therapies, used for at least three months 5. SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥7 at Screening 6. For LN cohort participants. Kidney biopsy result within 6 months prior to Screening indicating Class III or IV (alone or in combination w…
Anti-BCMA, Anti-CD19 Compound CAR-T Cells