Actively Recruiting
An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases
Led by Shanghai Cell Therapy Group Co.,Ltd · Updated on 2025-09-16
20
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA(BZE2204) in patients with relapsed or refractory active autoimmune diseases, including idiopathic inflammatory myopathies(IIM), immune thrombocytopenia(ITP), systemic lupus erythematosus(SLE).
CONDITIONS
Official Title
An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 70 years old
- Adequate bone marrow, liver, kidney, coagulation, and lung function as defined by study thresholds
- Life expectancy greater than 6 months
- For active IIM: diagnosis based on EULAR/ACR criteria with positive myositis-specific or associated antibodies, moderate to severe disease activity, and prior treatment failure or intolerance
- For active ITP: diagnosed for more than 3 months with low platelet counts, positive platelet autoantibodies, and prior treatment failure or relapse after splenectomy
- For active SLE: diagnosed for at least 6 months with positive autoantibodies, disease activity scores meeting criteria, biopsy-confirmed lupus nephritis if applicable, and prior treatment failure or intolerance
You will not qualify if you...
- History of severe allergic reactions or hypersensitivity to study drug components
- Serious heart disease as defined by the protocol
- Severe central nervous system symptoms within 6 months
- Current or past malignancy except as allowed by protocol
- Significant bleeding or clotting disorders within 6 months prior to screening
- Positive results for HIV, active hepatitis B or C, syphilis, or uncontrolled EBV/CMV infections
- Active or inadequately treated tuberculosis
- Uncontrolled infections requiring systemic treatment
- Failure to meet required treatment washout periods
- For IIM: inclusion body myositis, amyopathic dermatomyositis, severe muscle damage, or uncontrolled extramuscular disease
- For ITP: platelet count less than 10x10^9/L with active bleeding or high bleeding scores
- For SLE: lupus crisis within 3 months, active central nervous system lupus, severe hemolytic anemia or thrombocytopenic purpura
- Any other condition that may interfere with study participation or results 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
Shanghai Mengchao Cancer Hospital
Shanghai, Shanghai Municipality, China, 200240
Actively Recruiting
Research Team
J
Jinxing Lou
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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