Actively Recruiting
Exploratory Study of Anti-BCMA-CD19 CAR-T Cell Therapy in Relapsed or Refractory IgG4-Related Disease
Led by Chinese PLA General Hospital · Updated on 2025-09-03
9
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
X
Xuzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to test the safety and potential benefit of a new immune cell therapy called anti-BCMA-CD19 CAR-T cells in adults (18-75 years) with IgG4-related disease (IgG4-RD) that has come back or not improved after standard treatments such as glucocorticoids or rituximab. The main questions this study aims to answer are: * What medical problems (side effects) occur after receiving anti-BCMA-CD19 CAR-T cell therapy? * Does anti-BCMA-CD19 CAR-T cell therapy improve IgG4-RD disease activity scores at 12 weeks and 26 weeks? Participants will: * Have their own blood immune cells collected by a procedure called leukapheresis * Receive short-term chemotherapy to prepare the immune system * Receive one intravenous infusion of anti-BCMA-CD19 CAR-T cells * Return for regular clinic visits over 26 weeks for safety checks, blood tests, and imaging * May be followed for up to one year in total
CONDITIONS
Official Title
Exploratory Study of Anti-BCMA-CD19 CAR-T Cell Therapy in Relapsed or Refractory IgG4-Related Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, regardless of sex
- Meet the 2019 ACR/EULAR criteria for IgG4-related disease
- Involvement of two or more important organs or systems such as pancreas, bile ducts, kidneys, or dura mater
- Relapsed or refractory IgG4-RD after at least 3 months of glucocorticoid and/or rituximab therapy or relapse within 6 months post-treatment
- Adequate organ function including bone marrow (neutrophils = 1x10^9/L, hemoglobin = 60 g/L), liver (ALT and AST 3 times upper limit of normal, TBIL 1.5 times upper limit), kidney (creatinine clearance = 30 ml/min), coagulation (INR and PT 1.5 times upper limit), and stable heart function
- Women of childbearing potential and male partners must use contraception or abstain during treatment and for 12 months after
- Negative serum HCG test within 7 days before enrollment for women of childbearing potential
- Not breastfeeding
- Voluntary participation with signed informed consent and willingness to follow study procedures
- Adequate peripheral veins for intravenous infusion
You will not qualify if you...
- History of severe drug allergy or allergic constitution
- Current or suspected infections requiring treatment
- Central nervous system diseases excluding disease-related epilepsy, psychosis, brain syndrome, stroke, encephalitis, or vasculitis
- Cardiac insufficiency that prevents participation
- Congenital immunoglobulin deficiency
- Severe organ impairment due to congenital malformation or nutrition
- History of cancer within the past five years
- End-stage kidney failure
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with active infections
- Psychiatric disorders or severe cognitive problems
- Participation in other clinical trials within the past three months
- Use of investigational drugs within 12 weeks before screening or within five half-lives
- Pregnant or planning pregnancy
- Any other condition that the investigator believes prevents enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Rheumatology and Immunology, the First Medical Center, Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
Y
YIWEN WANG, M.D.
CONTACT
Y
YUFEI GUO, M.M.
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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