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.
Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF) and are willing to follow and be able to complete all trial procedures
Subjects disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases
Age: ≥ 18 years old and ≤ 70 years old, male or female
Subjects with estimated survival > 12 weeks
Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions
Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes
Subjects with active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections
Subjects with grade III or IV heart failure (NYHA classification)
Single group
CAR NK cells
DrugPatients will receive Fludarabine (30mg/m2 per day) and Cyclophosphamide on day -5, -4, and -3, followed by CAR NK cells infusion.
Incidence of Dose Limiting Toxicity (DLTs)
To characterize the safety of CAR NK Cells for moderate to severe autoimmune diseases.
Treatment Emergent Adverse Events（TEAEs）
To characterize the safety of CAR NK Cells for moderate to severe autoimmune diseases
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
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
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YANRU WANG
Lead sponsor
Affiliated Hospital of Jiangsu University
Sponsor institution
Rui Therapeutics Co., Ltd
Collaborator
