Actively Recruiting
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2026-02-03
15
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.
CONDITIONS
Official Title
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Major organ function must meet specific criteria for bone marrow, liver, kidney, heart, and lung function, with some exceptions for autoimmune disease activity
- Women of childbearing potential must use acceptable contraception or abstain during treatment and for 12 months after
- Written informed consent must be provided by participant or guardian
- For SLE: age 5 or older, meeting classification criteria, and specific treatment history and disease activity requirements
- For multi-drug resistant nephrotic syndrome: age 3 or older, diagnosed per guidelines, with treatment history as specified
- For IgA nephropathy: age 5 or older, biopsy confirmed, treated with ACE inhibitors or ARBs, and meeting proteinuria or kidney function decline criteria
- For systemic sclerosis: age 5 or older, meeting classification criteria, positive antibodies, skin score of 15 or more, and specific treatment history
- For ANCA-associated vasculitis: age 5 or older, meeting diagnostic criteria, treatment history of glucocorticoids plus immunosuppressants, and evidence of active vasculitis
You will not qualify if you...
- Known severe allergic reactions or hypersensitivity to study medications like cyclophosphamide or tocilizumab
- Grade III or IV heart failure or severe heart conditions including recent myocardial infarction, severe arrhythmias, or unstable vital signs
- Uncontrolled or active infections requiring systemic treatment
- Active pulmonary tuberculosis
- Positive tests for hepatitis B or C virus, HIV, syphilis, or cytomegalovirus beyond normal ranges
- History of severe herpes infection or recent herpes/varicella-zoster infection
- Active central nervous system disease
- History of malignant tumors
- Secondary or congenital immunodeficiency
- Significant medical conditions preventing administration of study therapy except lupus
- Recent organ or stem cell transplantation with acute graft-versus-host disease
- Receipt of live vaccine within 4 weeks before screening
- Positive pregnancy test
- Participation in other clinical trials with interventions within 3 months prior
- Clinically significant abnormal lab test results as judged by investigator
- Any other condition increasing risk or interfering with study outcomes as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
Research Team
J
Jianhua Mao, PhD
CONTACT
Q
Qiuyu Li, MD
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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