Actively Recruiting
An Exploratory Clinical Study to Evaluate Safety and Efficacy of Autologous CD19 CAR-T in Treating Relapsed/Refractory Autoimmune Diseases
Led by Beijing Boren Hospital · Updated on 2025-05-28
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary efficacy of autologous CD19 CAR-T therapy in adults aged 18 to 65 with relapsed or refractory autoimmune diseases, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), antineutrophil cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM), and Sjogren's syndrome (SS). This exploratory clinical trial uses a 3+3 dose escalation design to find the maximum tolerated dose and recommended dose. The study will monitor dose limiting toxicity (DLT) and follow participants for 24 months after treatment. Participants receive a single intravenous infusion of CD19 CAR-T cells at one of three dose levels, starting at 0.5 million CAR+ T cells per kilogram. If no severe toxicity occurs in three subjects at a dose level, the dose increases for the next group. If toxicity occurs, additional subjects are added or dosing is adjusted per protocol. The Safety Review Committee oversees dose escalation decisions based on safety, efficacy, and pharmacokinetic data. During the study, participants are closely monitored for side effects and treatment response, particularly for DLT within 28 days post-infusion. Follow-up includes safety and efficacy assessments over two years. Eligibility requires stable organ function and meeting disease-specific criteria. The study excludes individuals with active infections, certain cancers, recent use of specific medications, or significant cardiovascular disease. Participants must agree to effective contraception and provide informed consent.
CONDITIONS
Brief Title
Autologous CD19CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years, any gender
- Diagnosis of relapsed/refractory moderate to severe SLE meeting 2019 EULAR/ACR criteria with positive autoantibodies and active disease
- Diagnosis of relapsed/refractory diffuse cutaneous systemic sclerosis meeting 2013 EULAR/ACR criteria with interstitial lung disease and disease activity
- Diagnosis of relapsed/refractory antineutrophil cytoplasmic antibody-associated vasculitis with active disease per BVAS scoring
- Diagnosis of relapsed/refractory idiopathic inflammatory myopathy meeting 2017 EULAR/ACR criteria with muscle weakness and disease activity
- Diagnosis of relapsed/refractory Sjogren's syndrome with positive anti Ro/SSA antibodies and disease activity
- Stable organ function including blood counts, liver, kidney, heart, and lung function
- Use of effective contraception during treatment and for 24 months after
- Willingness to provide informed consent
You will not qualify if you...
- History or current active malignant tumors except certain treated cancers
- Severe pulmonary disease requiring oxygen or ventilation in past 3 months
- Recent use of B-cell depletion therapies or high-dose corticosteroids
- Severe central nervous system diseases or recent lupus crisis
- Severe kidney disease or active nephritis needing high-dose corticosteroids
- Allergies to study drugs or components
- Positive tests for hepatitis B, C, HIV, or syphilis
- Active or latent tuberculosis
- Recent major organ transplantation
- Recent severe cardiovascular events or uncontrolled hypertension
- Other autoimmune diseases needing systemic treatment
- Pregnancy or lactation
- Recent receipt of live vaccines
- Participation in other interventional clinical trials recently
- Mental illness with depression or suicidal tendencies
- Any other factors judged unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days after treatment
Participants receive escalating doses of autologous CD19 CAR-T cells to treat relapsed or refractory autoimmune diseases. Dose escalation follows a 3+3 design to determine the maximum tolerated dose.
1 infusion visit and multiple follow-up visits during the first 28 days
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
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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