RecruitingEarly Phase 1NCT06279923

CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases

Clinical Study of Targeting CD19-BAFF CAR-T Cells in the Treatment of Autoimmune Diseases

Sponsor

Zhejiang University

Enrollment

45 participants

Start Date

Apr 15, 2024

Study Type

INTERVENTIONAL

Conditions

Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases.

Min Age: 18 Years

\. Gender unlimited，18<Age;
\. 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
\. Estimated life expectancy of minimum of 12 weeks;
\. The blood routine meets the following standards:
Lymphocyte count>0.3×10e9/L;
Neutrophils ≥0.5×10e9/L;
Hemoglobin ≥60g/L;
Platelet ≥30×10e9/L
\. 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;
Those who voluntarily participated in this trial and provided informed consent;

\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
Pregnant or lactating women (the safety of this therapy for unborn children is still unknown)
\. Patients with HIV infection
\. Active infection of hepatitis B virus or hepatitis C virus;
\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
\. Creatinine>176.8 umol/L, or ALT / AST > 3 times of normal amounts, or bilirubin>51 umol/L;
\. Any unsuitable to participate in this trial judged by the investigator;
\. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 3 months;
\. Received immunosuppressive therapy within one week prior to mononuclear cell collection；
\. 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)；
\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.