Actively Recruiting
CD19 CAR-T in the Treatment of Relapsed/Refractory Autoimmune Diseases
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-12-24
15
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Autoimmune diseases such as systemic lupus erythematosus (SLE), diffuse cutaneous systemic sclerosis (dcSSc), antineutrophil cytoplasmic antibody (ANCA) -associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM), and Sjogren's syndrome (SS) have complex etiologies and are prone to cause systemic multiple organ damage. Because patients need lifelong medication due to repeated disease recurrence, and the current treatment of the above autoimmune diseases has limited efficacy and greater side effects, so that patients bear an excessive burden of disease, therefore, there is an urgent need to explore safer and more effective treatment. Several autologous CAR-T products targeting CD19 have been marketed for the treatment of B-cell hematological malignancies. Depletion of B cells to suppress abnormal immune responses is also currently one of the popular strategies for the treatment of antibody-mediated autoimmune diseases, and many clinical studies of CAR-T against autoimmune diseases are still ongoing. Therefore, a dose escalation trial is planned to evaluate the safety, tolerability, and preliminary efficacy of autologous CD19 CAR-T in patients with relapsed/refractory autoimmune diseases.
CONDITIONS
Official Title
CD19 CAR-T in the Treatment of Relapsed/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years, male or female
- Diagnosed with relapsed or refractory moderate to severe systemic lupus erythematosus (SLE) meeting 2019 EULAR/ACR criteria
- Positive antinuclear antibody or specific autoantibodies at screening
- Moderate to severe disease activity with SLEDAI-2000 score criteria
- Stable standard treatment for at least 6 months with active disease for at least 2 months before screening
- Diagnosed with relapsed or refractory diffuse cutaneous systemic sclerosis (dcSSc) meeting 2013 EULAR/ACR criteria
- Diffuse cutaneous manifestations and interstitial lung disease with specified lung function parameters
- Relapsed or refractory after prior conventional therapy for at least 6 months
- Evidence of disease activity including skin progression or lung function decline
- Diagnosed with relapsed or refractory antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) per 2012 Chapel Hill criteria
- Positive PR3-ANCA or MPO-ANCA antibody at screening
- Relapsed or refractory disease after prior immunosuppressive treatment
- Diagnosed with relapsed or refractory idiopathic inflammatory myopathy (IIM) with at least 55% probability per 2017 EULAR/ACR criteria
- Disease activity meeting muscle strength and other clinical measurement criteria
- Diagnosed with relapsed or refractory Sjogren's syndrome (SS) per 2016 EULAR/ACR criteria
- Anti-Ro/SSA antibody positivity and specified salivary flow rate at screening
- Disease activity defined by ESSDAI score
- Intolerance or insufficient efficacy to glucocorticoids and at least one other immunosuppressive agent with treatment for at least 3 months
- Good organ function defined by blood counts, coagulation, liver, kidney, cardiac, and pulmonary function
- Expected survival greater than 6 months
- Agreement to use effective contraception during treatment and for 24 months after
- Voluntary participation and signed informed consent form
You will not qualify if you...
- Previous or current active malignancies except certain cured cancers without recurrence for at least 2 years
- Severe lung disease or pulmonary hypertension requiring oxygen therapy or assisted ventilation
- Low immunoglobulin levels below normal at screening
- Recent use of B cell depletion therapy, high-dose intravenous immunoglobulin, or high-dose corticosteroids within specified time frames
- History of severe central nervous system diseases or related symptoms in the past 6 months
- Recent lupus crisis or severe lupus-related organ damage
- Severe kidney disease or active nephritis needing prohibited drugs or high-dose steroids
- Severe allergies to study drugs or CD19 CAR-T components
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Active uncontrolled infections
- History of major organ transplantation
- Active or latent tuberculosis
- Significant cardiovascular diseases or uncontrolled hypertension within 6 months before screening
- Other autoimmune diseases requiring systemic treatment beyond target indications
- Family history of certain myopathies
- Pregnant or lactating women
- Recent vaccination with live vaccine
- Participation in other interventional clinical studies within 3 months
- Depression or suicidal mental illness
- Other factors judged by researchers to affect participation or completion of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences Hospital of Hematology (Chinese Academy of Medical Sciences Institute of Hematology), Tianjin, 300020
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
W
wang ying
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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