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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Patients will receive Fludarabine (30mg/m2 per day) and Cyclophosphamide on day -5, -4, and -3, followed by CAR NK cells infusion.
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
RECRUITINGJiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, China
RECRUITINGIncidence of Dose Limiting Toxicity (DLTs)
To characterize the safety of CAR NK Cells for moderate to severe autoimmune diseases.
Time frame: within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion
Treatment Emergent Adverse Events(TEAEs)
To characterize the safety of CAR NK Cells for moderate to severe autoimmune diseases
Time frame: within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion
Disease control rate of subjects
To characterize the efficacy of CAR NK Cells for moderate to severe autoimmune diseases. Disease control is assessed according to SLEDAl 2K. Disease control rate is defined as proportion of patients with SRI-4 response: including SLEDAI 2K ≥ 4-Point improvement
Time frame: 4, 12, 24, and 52 weeks after infusion
Remission rate of subjects
To characterize the efficacy of CAR NK Cells for moderate to severe autoimmune diseases. Remission is assessed according to SLEDAl 2K. Remission rate is defined as proportion of patients with SLEDAl 2K score= 0
Time frame: 4, 12, 24, and 52 weeks after infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.