Actively Recruiting
Autologous CD19CAR-T Therapy for Recurrent/Refractory Autoimmune Diseases
Led by Beijing Boren Hospital · Updated on 2025-05-28
12
Participants Needed
1
Research Sites
131 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 autologous CD19 CAR-T therapy in subjects with autoimmune diseases. The study will adopt the traditional dose escalation model "3+3" design, with three dose groups set up, starting at a dose of 0.5 × 106 CAR+T cells/kg, to observe DLT, and conduct a 24 month safety and efficacy follow-up after cell infusion to observe the safety of autologous CD19 CAR-T and conduct preliminary efficacy evaluation. Three dose groups were set up, with dose group 1 as the starting dose, following the traditional 3+3 design rule for a single intravenous infusion: Dose group dosage unit (CAR+T cells/kg) Acceptable dose range Expected sample size (± 30%, CAR+T cells/kg) 1. 0.5 × 106 0.4 × 106\~0.6 × 106 3-6 cases 2. 1.0 × 106 0.7 × 106\~1.3 × 106 3-6 cases 3. 2.0 × 106 1.4 × 106\~2.6 × 106 3-6 cases Dose escalation rule The enrollment starts from dose group 1, and if no DLT occurs in the 3 subjects included, they will be transferred to the next dose group. If one of the three subjects in a certain dose group develops DLT, three additional subjects will be added to the group for cell infusion at the same dose. If there is ≥ 1 case of DLT in the 3 additional cases, it will be reduced to the previous dose group. If there are only 3 subjects in the previous dose group at this time, an additional 3 subjects need to be added for the trial; If there are already 6 subjects in the previous dose group, the trial ends and this dose is the maximum tolerated dose (MTD). Dose escalation is not allowed for the same subject. For safety reasons, the last subject in the previous dose group was observed for at least 28 days after autologous CD19 CAR-T infusion without DLT. The Safety Review Committee (SRC) held a meeting to decide whether to increase to the next dose group. During the dose escalation phase, SRC determines whether to continue increasing the dose or explore more subjects in a previously explored dose group based on the safety, efficacy, and pharmacokinetic (PK) results obtained for each dose group, and determines the recommended dose (RD) for subsequent studies.
CONDITIONS
Official Title
Autologous CD19CAR-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 (titer �3e= 1:80), anti-dsDNA, or anti-Sm antibodies
- SLEDAI-2000 score �3e= 8 or clinical symptom score �3e= 6 if low complement/anti-dsDNA present
- Stable standard treatment for at least 6 months with active disease for 2 months prior to screening
- Diagnosis of recurrent/refractory diffuse cutaneous systemic sclerosis (dcSSc) meeting 2013 EULAR/ACR criteria
- Evidence of interstitial lung disease with specified lung function limits
- Recurrent/refractory ANCA-associated vasculitis (AAV) meeting 2012 CHCC criteria with positive PR3-ANCA or MPO-ANCA
- Diagnosis of recurrent/refractory idiopathic inflammatory myopathy (IIM) with �3e= 55% probability and specific subtypes
- Diagnosis of recurrent/refractory Sjogren's syndrome (SS) meeting 2016 EULAR/ACR criteria with positive anti Ro/SSA antibodies
- Good organ function as defined by specified blood, liver, kidney, heart, and lung function tests
- Expected survival longer than 6 months
- Agreement to use effective contraceptive methods throughout treatment and 24 months after
- Signed informed consent form
You will not qualify if you...
- History or presence of active malignant tumors, with some exceptions for treated non-invasive cancers
- Severe pulmonary diseases requiring oxygen or ventilator support within past 3 months
- Low immunoglobulin levels during screening
- Recent use of B-cell depletion therapy, high-dose corticosteroids, tacrolizumab, or belimumab within defined timeframes
- History of severe central nervous system diseases or symptoms within past 6 months
- Severe lupus complications or crises within past 3 months
- Severe kidney disease or active nephritis requiring prohibited treatments
- Severe allergies to study drugs or components
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Uncontrolled infections deemed unsuitable by investigators
- History of major organ transplantation
- Active or latent tuberculosis during screening
- Recent significant cardiovascular events or uncontrolled hypertension
- Other autoimmune diseases requiring systemic treatment besides target indications
- Family history of certain myopathies
- Pregnant or breastfeeding women
- Recent live vaccine administration within 6 weeks
- Participation in other interventional clinical trials within 3 months
- Mental illness with depression or suicidal tendencies
- Other factors judged by investigators as unsuitable for participation
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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