A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of NEUK203-215 Injection in Adult Chinese Patients With Relapsed/Refractory Autoimmune Diseases

ConditionAutoimmune

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorNeukio Biotherapeutics (Shanghai) Co., Ltd.

About this trial

The purpose of this study is to determine the safety, tolerability and preliminary efficacy of NEUK203-215 , a healthy donor (HD) allogeneic CD19/BCMA-targeted CAR-NK cell product, in participants with severe, refractory autoimmune diseases.

Eligibility criteria

Qualifiers

1) Has provided signed informed consent; 2) Is aged 18-65 years ; 3)Adequate functional reserve of vital organs 4) Has a confirmed diagnosis of systemic lupus erythematosus, diffuse systemic sclerosis, inflammatory myopathy, or autoimmune bullous dermatosis.

Disqualifiers

1) Requires dialysis treatment. 2) History of severe drug hypersensitivity. 3) Active infection requiring systemic therapy or suspected uncontrolled infection.

Trial design

Treatments tested in this trial

Fludarabine
Cyclophosphamide (C)
NEUK203-215 Injection

Treatment groups

8 Participants

are divided into 1 treatment group

Sponsors and collaborators

Neukio Biotherapeutics (Shanghai) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov