Clinical Trial

An Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Primary Immune Thrombocytopenia

Recruiting Early Phase 1
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Record status
This record was last updated April 30, 2025 (before its estimated July 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 (KN5501) in patients with refractory immune thrombocytopenia. 9 patients are planned to be enrolled in the dose-escalation trial (9×10\^9 cells, 13.5×10\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate evaluation of KN5501 for the treatment of refractory immune thrombocytopenia. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with refractory immune thrombocytopenia.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-03-22; most recent amendment 2025-04-26.
Status change: Not Yet Recruiting → Recruiting 2025-04-26
Trial Details
NCT Number NCT06337474
Lead Sponsor Changzhou No.2 People's Hospital
Collaborators: Rui Therapeutics Co., Ltd
Conditions Thrombocytopenia Alloimmune
Enrollment 9 participants
Start Date 2024-08-30
Primary Completion 2025-07-30 (estimated)
Study Completion 2026-07-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-30