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

Launched by ZHEJIANG UNIVERSITY · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CD19-BAFF CAR-T cell therapy for patients with certain autoimmune diseases, which are conditions where the body's immune system mistakenly attacks its own tissues. The trial aims to find out if this therapy is safe and effective for people who have not responded to standard treatments for at least six months. Eligible participants are adults aged 18 and older who have been diagnosed with autoimmune diseases like lupus or systemic sclerosis and have tried multiple treatments without success.

If you or a loved one is considering participation, you can expect to receive this specialized therapy under the supervision of medical professionals. To be eligible, participants should have a certain level of health, including specific blood counts, and must not have certain medical conditions like severe heart disease or active infections. Everyone involved in this trial will need to give their consent, ensuring they understand what the trial involves. The study is currently recruiting participants, and it aims to contribute important information about potential new options for managing autoimmune diseases.

Gender

ALL

Eligibility criteria

• 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.