A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
NCT07328581
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Systemic Lupus Erythematosus (SLE)
- Lupus Nephritis (LN)
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- iCell Gene Therapeutics
- Last updated on ClinicalTrials.gov
- September 17, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
New York · 1
- NorthWell · New Hyde Park, NY
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.