Clinical Trial

An Exploratory Clinical Study of CD19 CAR NK Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases

Recruiting Phase 1
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Record status
This record was last updated August 29, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells in patients with autoimmune diseases. 36-72 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study was to evaluate the safety and feasibility of CD19 CAR-NK cells for the treatment of patients with autoimmune diseases. The secondary objective is to evaluate the efficacy of CD19 CAR-NK cells in patients with autoimmune diseases.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-06-13; most recent amendment 2025-08-27.
Status change: Not Yet Recruiting → Recruiting 2024-07-15
Trial Details
NCT Number NCT06464679
Lead Sponsor Changhai Hospital
Collaborators: Rui Therapeutics
Conditions Autoimmune Diseases
Enrollment 72 participants
Start Date 2024-06-27
Primary Completion 2025-12-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-08-29