Actively Recruiting
Safety and Efficacy of CD19 CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases
Led by Beijing Boren Hospital · Updated on 2025-05-21
12
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single center, open label exploratory clinical trial aimed at evaluating the safety and efficacy of universal CD19 CAR-T therapy in subjects with autoimmune diseases. The study will adopt the traditional dose escalation model "3+3" design, setting up three dose groups with a starting dose of 0.5 × 106 CAR+T cells/kg for incremental DLT observation. Safety and efficacy follow-up will be conducted for 24 months after cell infusion to observe the safety of the universal CD19 CAR-T and conduct preliminary efficacy evaluation.
CONDITIONS
Official Title
Safety and Efficacy of CD19 CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old, any gender
- Diagnosed with relapsed or refractory moderate to severe systemic lupus erythematosus (SLE) meeting 2019 EULAR/ACR criteria
- Positive for antinuclear antibody, anti-dsDNA, or anti-Sm antibodies during screening
- Moderate to severe disease activity with SLEDAI-2000 score at least 8
- At least 6 months of stable standard SLE treatment prior to screening
- Diagnosed with relapsed or refractory diffuse cutaneous systemic sclerosis (dcSSc) meeting 2013 EULAR/ACR criteria
- Presence of interstitial lung disease with specific lung function measurements
- Relapsed or refractory ANCA-associated vasculitis (AAV) diagnosed by 2012 CHCC criteria
- Positive for PR3-ANCA or MPO-ANCA antibodies during screening
- Diagnosed with relapsed or refractory idiopathic inflammatory myopathy (IIM) with probability at least 55% per 2017 EULAR/ACR criteria
- Disease activity with specified muscle strength and enzyme levels
- Diagnosed with relapsed or refractory Sjogren's syndrome (SS) meeting 2016 EULAR/ACR criteria
- Positive for anti Ro/SSA antibodies during screening
- Good organ function including blood counts, liver and kidney function, cardiac and pulmonary function
- Expected survival longer than 6 months
- Use of effective contraception during treatment period and for 24 months after
- Negative pregnancy test for women of childbearing age
- Voluntary informed consent signed
You will not qualify if you...
- History or presence of active malignant tumors except certain treated cancers
- Severe pulmonary diseases requiring oxygen or ventilation within past 3 months
- Use of B-cell depletion therapy or high-dose corticosteroids within specified recent timeframes
- History of severe central nervous system diseases or symptoms within past 6 months
- Recent lupus crisis or severe active lupus manifestations
- Severe kidney disease or active nephritis requiring prohibited treatments
- Severe allergies to study drugs
- Positive for hepatitis B, hepatitis C, HIV, or syphilis antibodies
- Uncontrolled infections deemed unsuitable by researchers
- History of major organ transplantation
- Active or latent tuberculosis
- Recent serious cardiovascular diseases or arrhythmias
- Uncontrolled hypertension or hypertensive emergencies
- History of other autoimmune diseases requiring systemic treatment
- Family history of non-idiopathic inflammatory myopathy
- Pregnant or breastfeeding women
- Receipt of live vaccine within 6 weeks prior to treatment
- Participation in other interventional clinical trials within 3 months
- Mental illness with depression or suicidal tendencies
- Any other factors deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Gobroad Brond Hospital
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
Y
yajing zhang, MD/PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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