CAR-T cell therapy targeting specific markers in autoimmune diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of chimeric antigen receptor T cell (CAR-T) immunotherapy targeting BCMA and CD19 in patients with relapsed or refractory autoimmune diseases, including systemic lupus erythematosus and Sjogren's syndrome. The study is open-label and single-arm, focusing on assessing the safety profile, including potential cytokine storms, and the treatment's impact on disease status. Participants will receive CAR-T cells designed to target specific B cell markers associated with their autoimmune conditions. The trial aims to enhance understanding of CAR-T cell functionality and persistence in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Expected survival time ≥3 months;
* Subjects with recurrent/refractory autoimmune diseases who have failed standard treatment or lack effective treatment, Including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associated diseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.
* Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.
* Liver and kidney function, cardiopulmonary function meet the following requirements:
* Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;
* Blood oxygen saturation \>91% in non-oxygen state;
* Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.
* No serious mental disorders;
* Can understand this test and have signed the informed consent.

Exclusion Criteria:

* Malignant tumors other than R/R AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
* Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive;
* Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;
* Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;
* Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;
* Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion;
* Patients who received CAR-T therapy or other gene-modified cell therapy before screening;
* Participated in other clinical studies 1 month before screening;
* Evidence of central nervous system invasion during subject screening;
* Mental patients with depression or suicidal thoughts;
* Situations considered unsuitable for inclusion by other researchers.

Where it's running

• District One Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Rhoda M Smith, Phd
• Email: clinical-trials@essen-biotech.com
• Phone: +12077706670

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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• ATG-201 in adults with autoimmune diseases

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• In vivo CAR-T therapy Arnovie101 for B cell–mediated autoimmune diseases

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  Recruiting Early Phase 1 Circunited BioPharma (Shenzhen) Co., Ltd. · Beijing, Beijing Municipality · NCT07629596

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.