A Clinical Study of CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases
Condition(s) studied
Investigational drug(s) / intervention(s)
CAR NK cells: Patients will receive Fludarabine (30mg/m2 per day) and Cyclophosphamide on day -5, -4, and -3, followed by CAR NK cells infusion.
Study 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
Primary outcome measure(s)
- Incidence of Dose Limiting Toxicity (DLTs) — within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion
To characterize the safety of CAR NK Cells for moderate to severe autoimmune diseases. - Treatment Emergent Adverse Events(TEAEs) — within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion
To characterize the safety of CAR NK Cells for moderate to severe autoimmune diseases
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | Recruiting |
| Jiangsu University Affiliated Hospital | Zhenjiang | Jiangsu | Recruiting |
More YANRU WANG trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06318533 on ClinicalTrials.gov ↗ ← All trials in China