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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Primary completion date: Jun 30, 2025 to Dec 30, 2025
    • Eligibility criteria expanded, about 7 words
    v4
  2. Interventions: CD19 CAR NK cells (Drug) to anti-CD19 CAR NK cells (Biological)v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 30, 2024 to Jun 27, 2024
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Changhai Hospital
121 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT06464679
Lead Sponsor Changhai Hospital
Collaborators: Rui Therapeutics
Conditions
(from sponsor)		 Autoimmune Diseases
Related terms Autoimmune Diseases
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov