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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 andImmunosuppressants,Immunomodulator or Biological agents) are ineffective for more than 6 months or reappear with disease activity and/or no effective treatment after diseaseremission
- 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 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:
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascularischemia, and cerebrovascular hemorrhagic diseases;
- 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)
- 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-stimulationsignal;
- Creatinine>176.8 umol/L, or ALT / AST > 3 times of normal amounts, or bilirubin>51umol/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 genemodified cell therapy product within 3 months;
- Received immunosuppressive therapy within one week prior to mononuclear cellcollection;
- 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);
- 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
Connect with a study center
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang 310000
ChinaActive - Recruiting
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