CD19-BAFF CAR-T cell therapy for 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 CD19-BAFF CAR-T cell therapy in 45 patients suffering from various autoimmune diseases, including Systemic Lupus Erythematosus, Systemic sclerosis, Dermatomyositis, Immune nephritis, and Neuromyelitis optica. Patients who have not responded to standard treatments for over six months will receive this innovative therapy. The study aims to gather more safety data and assess the effectiveness of this targeted approach in treating these challenging conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Gender unlimited，18\<Age;
* 2\. Diagnosed as Autoimmune Diseases（Systemic Lupus Erythematosus，Immune nephritis, Systemic sclerosis，Dermatomyositis，Neuromyelitis optica）and after routine treatment (using more than 2 types drugs, such as hormones and Immunosuppressants，Immunomodulator or Biological agents) are ineffective for more than 6 months or reappear with disease activity and/or no effective treatment after disease remission
* 3\. Estimated life expectancy of minimum of 12 weeks;
* 4\. The blood routine meets the following standards:

  1. Lymphocyte count\>0.3×10e9/L;
  2. Neutrophils ≥0.5×10e9/L;
  3. Hemoglobin ≥60g/L;
  4. Platelet ≥30×10e9/L
* 5\. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
* 6.Those who voluntarily participated in this trial and provided informed consent;

Exclusion Criteria:

* 1\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
* 2\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
* 3.Pregnant or lactating women (the safety of this therapy for unborn children is still unknown)
* 4\. Patients with HIV infection
* 5\. Active infection of hepatitis B virus or hepatitis C virus;
* 6\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
* 7\. Creatinine\>176.8 umol/L, or ALT / AST \> 3 times of normal amounts, or bilirubin\>51 umol/L;
* 8\. Any unsuitable to participate in this trial judged by the investigator;
* 9\. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 3 months;
* 10\. Received immunosuppressive therapy within one week prior to mononuclear cell collection；
* 11\. ndividuals who have used systemic steroid drugs exceeding 20mg/d of prednisone or equivalent doses within one week prior to treatment (excluding those who have recently or are currently using inhaled steroids)；
* 12\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

Where it's running

• The first affiliated hospital of medical college of zhejiang university
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: He Huang, MD — Zhejiang University
• Study coordinator: He Huang, MD
• Email: hehuangyu@126.com
• Phone: 86-13605714822

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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.