Actively Recruiting
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-09-29
12
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
S
Shanghai Xiniao Biotech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
CONDITIONS
Official Title
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Positive expression of CD19 or BCMA on peripheral blood B cells confirmed by flow cytometry
- Bone marrow function with neutrophil count 2 1�d7109/L without colony-stimulating factor treatment within 2 weeks, hemoglobin 2 60g/L
- Liver function with ALT 2 3 times upper limit of normal (ULN) (excluding inflammatory myopathy causes), AST 2 3 times ULN (excluding inflammatory myopathy causes), total bilirubin 2 times ULN (or 2 3 times ULN for Gilbert syndrome)
- Renal function with creatinine clearance rate 2 30ml/min (acute decrease due to target disease excluded)
- ECOG performance status 0-2
- Use of medically approved contraception or abstinence during treatment and for 6 months after
- Negative pregnancy test within 7 days before enrollment and not lactating (for females of childbearing potential)
- Willingness to participate, sign consent, comply with follow-up
- Disease-specific criteria for refractory or relapsed systemic lupus erythematosus, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, or connective tissue disease-associated thrombocytopenia as detailed in protocol
You will not qualify if you...
- History of severe drug allergies or allergic tendencies
- Uncontrolled or treated fungal, bacterial, viral, or other infections
- Central nervous system diseases including epilepsy, psychosis, organic brain syndrome, stroke, encephalitis, or CNS vasculitis
- Insufficient heart function
- Congenital immunoglobulin deficiencies
- Cancer history within past five years
- End-stage renal failure (excluding lupus nephritis)
- Positive for hepatitis B surface antigen or core antibody with high HBV DNA, hepatitis C antibody with RNA, HIV antibody, or positive syphilis test
- Psychiatric disorders or severe cognitive impairment
- Participation in other clinical trials within past 3 months
- Recent use of immunosuppressive agents or biologics within 5 half-lives
- Pregnant or planning pregnancy
- Other investigator-determined reasons for unsuitability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Actively Recruiting
Research Team
Y
Ying Wang, 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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