Actively Recruiting
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Led by Changhai Hospital · Updated on 2026-02-25
60
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
R
Rui Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cells in patients with autoimmune diseases. 60 patients are planned to be enrolled in the dose-escalation trial.
CONDITIONS
Official Title
Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, male or female
- Adequate organ function including neutrophil count 61 1 x 10^9/L and hemoglobin 60 g/L
- Liver function within limits: ALT 64 x ULN, AST 64 x ULN, total bilirubin 61.5 x ULN
- Coagulation function within limits: INR 641.5 x ULN, PT 641.5 x ULN
- Good cardiac function with left ventricular ejection fraction 61 50%
- Use of approved contraception or abstinence for 6 months during and after treatment if of childbearing potential
- Negative serum HCG test within 7 days before enrollment for females of childbearing potential and not lactating
- Willingness to participate voluntarily and comply with study procedures
- Diagnosis of relapsed/refractory autoimmune diseases meeting specific disease criteria for systemic lupus erythematosus, systemic sclerosis, primary Sj�f6gren syndrome, rheumatoid arthritis, or ANCA-associated vasculitis
- Disease activity and treatment history meeting defined thresholds and criteria for each autoimmune condition
You will not qualify if you...
- Known severe allergic reactions or hypersensitivity to trial medications including cyclophosphamide, fludarabine, or tozumabs
- Presence or suspicion of uncontrolled infections
- Central nervous system disorders from any cause including epilepsy or psychiatric disorders
- Serious heart diseases such as angina, myocardial infarction, heart failure, or arrhythmia
- Congenital immunoglobulin deficiency
- Malignant tumors except certain skin and in situ cancers disease-free for over 5 years
- End-stage renal failure
- Positive for hepatitis B or C viruses, HIV, or syphilis
- Mental illness or severe cognitive impairment
- Participation in another clinical trial within 6 months
- Pregnant or planning pregnancy
- Uncontrolled hypertension or diabetes
- Other conditions deemed by investigators to prevent study participation
- Specific exclusions related to each autoimmune disease including other major interfering disorders, active skin diseases, cirrhosis, aplastic anemia, severe rheumatoid arthritis, or severe kidney impairment requiring ventilation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China
Actively Recruiting
Research Team
D
Dongbao Zhao
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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