A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
A Phase IIa, Open-Label, Single-Arm Study With an Initial Safety Run-In and Dose Expansion of ICG318 (BCMA-CD19-IL-15/IL15sushi cCAR T) in Participants With Refractory Systemic Lupus Erythematosus, With or Without Lupus Nephritis
iCell Gene Therapeutics
20 participants
Sep 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Anti-BCMA, Anti-CD19 Compound CAR-T Cells
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT07328581