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

Last updated: April 8, 2024
Sponsor: Zhejiang University
Overall Status: Active - Recruiting

Phase

1

Condition

Connective Tissue Diseases

Collagen Vascular Diseases

Treatment

CD19-BAFF Targeted CAR T-cells

Clinical Study ID

NCT06279923
TXB2023023
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Gender unlimited,18<Age;
    1. 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 andImmunosuppressants,Immunomodulator or Biological agents) are ineffective for more than 6 months or reappear with disease activity and/or no effective treatment after diseaseremission
    1. Estimated life expectancy of minimum of 12 weeks;
    1. 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
    1. Pregnant/lactating women, or male or female patients who have fertility and arewilling to take effective contraceptive measures at least 6 months after the last cellinfusion during the study period;
  • 6.Those who voluntarily participated in this trial and provided informed consent;

Exclusion

Exclusion Criteria:

    1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascularischemia, and cerebrovascular hemorrhagic diseases;
    1. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severearrhythmia in the past;
  • 3.Pregnant or lactating women (the safety of this therapy for unborn children is stillunknown)
    1. Patients with HIV infection
    1. Active infection of hepatitis B virus or hepatitis C virus;
    1. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulationsignal;
    1. Creatinine>176.8 umol/L, or ALT / AST > 3 times of normal amounts, or bilirubin>51umol/L;
    1. Any unsuitable to participate in this trial judged by the investigator;
    1. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other genemodified cell therapy product within 3 months;
    1. Received immunosuppressive therapy within one week prior to mononuclear cellcollection;
    1. ndividuals who have used systemic steroid drugs exceeding 20mg/d of prednisone orequivalent doses within one week prior to treatment (excluding those who have recentlyor are currently using inhaled steroids);
    1. Any situation that researchers believe may increase the risk to the subjects orinterfere with the trial results.

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: CD19-BAFF Targeted CAR T-cells
Phase: 1
Study Start date:
April 15, 2024
Estimated Completion Date:
February 01, 2027

Study Description

In this study, 45 patients with Autoimmune Diseases include Systemic Lupus Erythematosus、Systemic sclerosis、Dermatomyositis、Immune nephritis and Neuromyelitis optica were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for Autoimmune Diseases; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for Autoimmune Diseases were accumulated, including rare and delayed complications.

Connect with a study center

  • The first affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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