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An Exploratory Clinical Study of Anti-CD19 CAR NK Cell (KN5501) in the Treatment of Relapsed/Refractory Immune Nephropathy

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Jun 20, 2025 to Jun 20, 2026
    • Study completion date: Jun 20, 2026 to Jun 20, 2027
    v4
  2. Interventions: KN5501 (Drug) to anti-CD19 CAR NK cells (Biological)
    • Secondary endpoints: details revised at 4 of 4 entries
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 20, 2024 to Jun 21, 2024
    • Collaborator revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 anti-CD19 CAR NK cell injection (KN5501) in patients with immune nephropathy. 36 patients are planned to be enrolled in the dose-escalation trial. The primary endpoints are DLT and TEAEs. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR)
Trial Details
NCT Number NCT06469190
Lead Sponsor Changhai Hospital
Collaborators: Rui Therapeutics Co., Ltd
Conditions
(from sponsor)		 Nephropathy
Related terms Kidney Diseases
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov