Actively Recruiting
An Exploratory Clinical Study of CD19 CAR NK Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Led by Changhai Hospital · Updated on 2025-08-29
72
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
Changhai Hospital
Lead Sponsor
R
Rui Therapeutics
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 CD19 CAR NK cells in patients with autoimmune diseases. 36-72 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study was to evaluate the safety and feasibility of CD19 CAR-NK cells for the treatment of patients with autoimmune diseases. The secondary objective is to evaluate the efficacy of CD19 CAR-NK cells in patients with autoimmune diseases.
CONDITIONS
Official Title
An Exploratory Clinical Study of CD19 CAR NK Cell Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years, any gender
- Adequate bone marrow function with white blood cell count ≥ 3 x 10^9/L, neutrophil count ≥ 1 x 10^9/L (no colony-stimulating factor treatment within 2 weeks), and hemoglobin ≥ 60 g/L
- Liver function with ALT and AST ≤ 3 times upper limit of normal (ULN), total bilirubin ≤ 1.5 times ULN (or ≤ 3.0 times ULN if Gilbert syndrome), excluding disease-caused conditions
- Renal function with creatinine clearance rate ≥ 60 ml/min
- Coagulation function with INR < 1.5 x ULN and prothrombin time < 1.5 x ULN
- Good cardiac function and hemodynamic stability
- Female participants of childbearing potential and male partners must use medically approved contraception or abstain from sex during and for 6 months after treatment
- Female participants of childbearing potential must have a negative serum HCG test within 7 days before enrollment and not be lactating
- Voluntary participation with informed consent, good compliance, and willingness to follow up
- Meet specific disease criteria for relapsing refractory dry syndrome, systemic sclerosis, recurrent refractory idiopathic inflammatory myopathy, or relapsing refractory rheumatoid arthritis as defined by established classification and activity criteria
- Ineffective conventional treatment or relapse after remission, with detailed definitions for routine treatment and refractory disease for each condition
You will not qualify if you...
- Known severe allergic reactions or hypersensitivity to study medications (cyclophosphamide, fludarabine, tozumabs)
- Active or uncontrolled infections requiring treatment
- Central nervous system disorders including epilepsy, psychosis, encephalopathy, stroke, encephalitis, or vasculitis
- Serious heart diseases such as angina, myocardial infarction, heart failure, or arrhythmia
- Congenital immunodeficiency diseases
- Malignant tumors except certain skin and in situ cancers disease-free for over 5 years
- End-stage renal failure
- Positive for hepatitis B surface antigen or core antibody with high HBV DNA, hepatitis C virus antibodies and RNA, HIV antibodies, or syphilis
- Mental illness or severe cognitive impairment
- Participation in another clinical trial within 3 months
- Pregnant or intending to conceive women
- Additional exclusions for specific diseases including liver cirrhosis or myelodysplastic syndromes for dry syndrome, drug-induced or tumor-associated myositis for inflammatory myopathies, and severe functional status (level 4) for rheumatoid arthritis
- Other reasons deemed by investigators to exclude participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Changhai Hospital
Shanghai, China
Actively Recruiting
Research Team
D
Dongbao Zhao, Dr
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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