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A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Phase changed: Phase 1/2 → Phase 2 Show 8 more changesShow less
    • Recruitment opened
    • Start date: Jan 2026 to Sep 2026
    • Trial sites expanded: 0 → 4 locations
    • Interventions modified
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 4 of 14 entries
    • Study title expanded, about 8 words
    • Study description shortened, about 1 word
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07328581
Lead Sponsor iCell Gene Therapeutics
Conditions
(from sponsor)		 Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
Related terms Autoimmune Diseases, Disease, Lupus Erythematosus, Systemic, Lupus Nephritis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov