NCT06337474

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

An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cell Injections for the Treatment of Refractory Primary Immune Thrombocytopenia

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Changzhou No.2 People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombocytopenia Alloimmune

Interventions

Type	Name	Description
DRUG	anti-CD19 CAR NK cells (KN5501)	Patients will receive Fludarabine (25 mg/m2 per day) and Cyclophosphamide (1000mg/m2 per day) on day -3. Doses of 9×10\^9 cells, 13.5×10\^9 anti-CD19 CAR NK cells (KN5501) will infused in each group using the dose-escalation strategy

Timeline

• Start date: 2024-08-30
• Primary completion: 2025-07-30
• Completion: 2026-07-30
• First posted: 2024-03-29
• Last updated: 2025-04-30

Locations

1 site across 1 country: China