Clinical Trial

A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis

Study acronym: RECLAIM-LN
Not Yet Recruiting Phase 2
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Summary
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-30.
Trial Details
NCT Number NCT07570862
Lead Sponsor Fate Therapeutics
Conditions Lupus Nephritis, Systemic Lupus Erythematosus, SLE - Systemic Lupus Erythematosus, Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV
Enrollment 53 participants
Start Date 2026-07-01
Primary Completion 2029-07-01 (estimated)
Study Completion 2030-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-11