ICG318 CAR-T for Lupus
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for people aged 16-70 with systemic lupus erythematosus (SLE) who haven't responded to at least two standard treatments. They must have active disease and certain antibody markers. Those with or without kidney involvement (lupus nephritis) may join if they meet specific criteria.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- ICG318
Trial Overview
The study tests a single infusion of ICG318 CAR-T cells after lymphodepletion in people with hard-to-treat SLE, including those with lupus nephritis. All participants receive the same treatment; there is no placebo group.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Biologic drug infusion
Find a Clinic Near You
Who Is Running the Clinical Trial?
iCell Gene Therapeutics
Lead Sponsor
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