Actively Recruiting
Exploratory Clinical Study Evaluating the Safety and Efficacy of Universal 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
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and initial effectiveness of universal CD19 CAR-T therapy in adults with recurrent or refractory autoimmune diseases. This exploratory clinical trial uses a traditional dose escalation design to carefully observe dose limiting toxicities (DLTs) and establish a maximum tolerated dose. The study aims to provide important early data on how this genetic treatment may work for these challenging autoimmune conditions under medical supervision. Participants will receive one of three doses of CD19 CAR-T cells, starting at 0.5 million CAR+ T cells per kilogram of body weight, with doses increasing based on safety observations. The trial follows a "3+3" dose escalation method, enrolling small groups at each dose level and monitoring closely for adverse effects. If toxicities occur, adjustments are made including adding more participants or lowering doses. After treatment, participants are followed for 24 months to monitor safety and gather preliminary effectiveness data. Throughout the study, participants will undergo regular safety assessments focused on detecting dose limiting toxicities within the first 28 days after treatment. They will be monitored closely for side effects and health changes. The trial includes detailed eligibility screening based on diagnosis and disease activity, along with laboratory tests and clinical evaluations to ensure suitability and safety. Participants will be observed for up to two years after infusion to evaluate longer-term safety and treatment outcomes.
CONDITIONS
Brief 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
- Diagnosis of relapsed or refractory moderate to severe systemic lupus erythematosus (SLE) meeting 2019 EULAR/ACR criteria
- Positive for ANA, anti-dsDNA, or anti-Sm antibodies during screening
- SLEDAI-2000 score of 8 or higher indicating active disease
- At least 6 months of stable standard treatment with persistent disease activity
- Diagnosis of recurrent/refractory diffuse cutaneous systemic sclerosis (dcSSc) with interstitial lung disease meeting 2013 EULAR/ACR criteria
- Diagnosis of recurrent/refractory ANCA-associated vasculitis (AAV) with positive PR3-ANCA or MPO-ANCA and active disease
- Diagnosis of recurrent/refractory idiopathic inflammatory myopathy (IIM) with disease activity meeting 2017 EULAR/ACR criteria
- Diagnosis of recurrent/refractory Sjogren's syndrome (SS) with anti-Ro/SSA antibodies and active disease
- Good organ function including blood counts, coagulation, liver, kidney, heart, and lung function within defined limits
- Expected survival longer than 6 months
- Use of effective contraception during treatment and for 24 months after
- Negative pregnancy tests for women of childbearing potential
- Ability and willingness to provide informed consent
You will not qualify if you...
- History or current active malignant tumors except certain treated cancers
- Severe pulmonary diseases requiring oxygen or ventilator support
- Low immunoglobulin levels (IgA, IgG, IgM) below normal
- Recent use of B-cell depletion therapies or high-dose corticosteroids
- Use of certain immunotherapies within defined recent periods
- History of severe central nervous system diseases or symptoms in past 6 months
- Recent lupus crisis or severe organ involvement
- Severe kidney disease or active nephritis requiring prohibited treatments
- Severe allergies to study drugs
- Positive tests for hepatitis B or C, syphilis, or HIV
- Uncontrolled infections
- History of major organ transplantation
- Active or latent tuberculosis
- Recent serious cardiovascular events or uncontrolled hypertension
- Other autoimmune diseases requiring systemic treatment besides target indications
- Pregnancy or breastfeeding
- Recent live vaccination
- Participation in other interventional clinical trials within 3 months
- Mental illness with depression or suicidal tendencies
- Other factors deemed 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 CD19 CAR-T therapy with dose escalation to evaluate safety and efficacy.
1 treatment 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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