A Clinical Study of CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases
An Exploratory Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor NK Cell Injections for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases
YANRU WANG
15 participants
Mar 13, 2024
INTERVENTIONAL
Conditions
Summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of CAR NK cells in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial . The primary objective of the study is to evaluation of the safety and feasibility of CAR NK cells for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of CAR NK cells for the treatment of relapsed/refractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete B cells of CAR NK cells in patients with relapsed/refractory B-cell related autoimmune diseases.
Eligibility
Plain Language Summary
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Interventions
Patients will receive Fludarabine (30mg/m2 per day) and Cyclophosphamide on day -5, -4, and -3, followed by CAR NK cells infusion.
Locations(2)
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NCT06318533