Actively Recruiting
Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases
Led by Essen Biotech · Updated on 2024-11-05
60
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or CD19 or both sequentially in the treatment of Relapsed/ Refractory Autoimmune Disease such as Sjogren's Syndrome or Systemic Lupus Erythematosus and other Autoimmune Disease.
CONDITIONS
Official Title
Sequential CAR-T Cells Targeting BCMA/CD19 in Patients With Relapsed/ Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Expected survival time of at least 3 months
- Diagnosed with relapsed or refractory autoimmune diseases, including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associated diseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, or primary biliary cholangitis
- Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction
- Liver and kidney function meeting: creatinine �3� 1.5 times upper limit of normal (ULN); total bilirubin �3� 2 times ULN; ALT and AST �3� 2.5 times ULN unless due to disease-related causes, then less than 5 times ULN; for Gilbert syndrome, total bilirubin up to 3 times ULN and direct bilirubin up to 1.5 times ULN
- Cardiopulmonary function including normal electrocardiogram without significant abnormalities and blood oxygen saturation over 91% without oxygen
- No serious mental disorders
- Ability to understand the trial and provide informed consent
You will not qualify if you...
- Malignant tumors other than relapsed/refractory autoimmune disease in the past 5 years, except certain treated cancers (cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer after surgery, breast ductal carcinoma in situ after surgery)
- Positive for hepatitis B surface antigen or core antibody with abnormal hepatitis B virus DNA, positive hepatitis C antibody with hepatitis C RNA, HIV antibody positive, or positive for syphilis
- Serious heart disease including unstable angina, recent myocardial infarction or cardiac surgery within 6 months, severe congestive heart failure (NYHA III or higher), or severe arrhythmia
- Unstable systemic diseases requiring drug treatment such as severe liver, kidney, or metabolic disease
- Active or uncontrolled infections requiring systemic treatment within 7 days prior to treatment, excluding mild genitourinary or upper respiratory infections
- Pregnant or lactating women, or those planning pregnancy within 2 years after cell transfusion; male partners of women planning pregnancy within 2 years after cell transfusion
- Previous CAR-T or other gene-modified cell therapy before screening
- Participation in other clinical studies within 1 month prior to screening
- Evidence of central nervous system involvement during screening
- Mental illness with depression or suicidal thoughts
- Any other condition deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
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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