Clinical Trial

An Exploratory Clinical Study of Anti-CD19 CAR NK Cells in the Treatment of Systemic Lupus Erythematosus

Recruiting Early Phase 1
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Summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-cluster of differentiation antigen 19 (CD19) chimeric antigen receptor (CAR) natural killer (NK) cells (KN5501) in patients with moderate to severe refractory systemic lupus erythematosus (SLE). 36 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study was to evaluate the safety of allogeneic anti-CD19 CAR-NK cells (KN5501) for the treatment of patients with moderate to severe refractory active SLE. The secondary objective is to evaluate the efficacy of anti-CD19 CAR NK cells (KN5501) in patients with moderate to severe refractory SLE, including British Isles Lupus Assessment Group 2004 (BILAG-2004) index, Systemic Lupus Erythematosus Responder Index (SRI)-4 response rate, Lupus Low Disease Activity State (LLDAS) rate, and Definitions Of Remission In SLE (DORIS) remission rate.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2023-08-23; most recent amendment 2025-04-26.
Trial Details
NCT Number NCT06010472
Lead Sponsor Changhai Hospital
Collaborators: Rui Therapeutics Co., Ltd
Conditions Systemic Lupus Erythematosus (SLE)
Enrollment 36 participants
Start Date 2023-08-20
Primary Completion 2026-08-25 (estimated)
Study Completion 2027-08-25 (estimated)
Updated on ClinicalTrials.gov 2025-04-29