Actively Recruiting
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of NEUK203-215 Injection in Adult Chinese Patients With Relapsed/Refractory Autoimmune Diseases
Led by Neukio Biotherapeutics (Shanghai) Co., Ltd. · Updated on 2025-08-27
8
Participants Needed
1
Research Sites
71 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of NEUK203-215 Injection in Adult Chinese Patients With Relapsed/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has provided signed informed consent
- Is aged 18-65 years
- Has adequate functional reserve of vital organs
- Has a confirmed diagnosis of systemic lupus erythematosus, diffuse systemic sclerosis, inflammatory myopathy, or autoimmune bullous dermatosis
You will not qualify if you...
- Requires dialysis treatment
- Has a history of severe drug hypersensitivity
- Has an active infection requiring systemic therapy or a suspected uncontrolled infection
- Has had certain cardiovascular events within 6 months before screening, including NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or clinically significant cardiac disease
- Has had malignancy within the past 5 years
- Has clinically significant chronic or intermittent bleeding within 60 days before screening
- Has had prior solid-organ or hematopoietic stem-cell/bone-marrow transplantation
- At screening, tests positive for certain infections including hepatitis B, hepatitis C, HIV, or syphilis
- Has had major surgery within 4 weeks before screening
- Has received a live or live-attenuated vaccine within 4 weeks before screening
- Has uncontrolled concurrent medical conditions
- Has a documented history of neurologic or psychiatric disorders
- Has any other factor that could require premature withdrawal from the study according to the investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200131
Actively Recruiting
Research Team
H
Huji Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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