A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome

  • STATUS
    Recruiting
  • End date
    Nov 5, 2024
  • participants needed
    9
  • sponsor
    Zhejiang University
Updated on 28 October 2021
sjogren's syndrome

Summary

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome

Description

Autoimmune diseases only show local pathological damage, but more often systemic lesions. If not diagnosed and treated in time or poorly controlled, a risk of disability or even death as the course of the disease progresses. Studies have shown that B cells can present their own antigens to autoimmune T cells to promote the release of inflammatory factors, or they can differentiate into plasma cells to release autoantibodies, and play an important role in the occurrence and progression of autoimmune diseases. In recent years, it has become a major research focus to deplete B cells in patients or inhibit B cell function. This research focuses on CAR-T cells killing B cells. Sjgren's syndrome (SS) is a systemic autoimmune disease characterized by chronic inflammation of salivary and lachrymal glands, frequently accompanied by systemic symptoms. The presence of various autoantibodies such as rheumatoid factor (RF) and anti-SSA/SSB antibodies, as well as hypergammaglobulinemia, reflect B cell hyperactivity. About five percent of patients with SS develop malignant B cell lymphoma, usually of the mucosa-associated lymphoid tissue (MALT) type and most frequently located in the major salivary glands. This fully reflects the application prospects of CAR-T cells in autoimmune diseases.

Based on the current research progress, our center intends to conduct research on the safety and effectiveness of CD19/BCMA CAR-T cells in the treatment of refractory systemic lupus erythematosus.

Details
Condition Rheumatoid Arthritis, Sicca Syndrome, Rheumatoid Arthritis (Pediatric), Autoimmune disease, autoimmune disorders, Dry Mouth, autoimmune diseases, Xerostomia, Autoimmunity, autoimmune disorder, Sjogren's Syndrome, Autoimmune Disease
Treatment Assigned Interventions CD19/BCMA CAR T-cells
Clinical Study IdentifierNCT05085431
SponsorZhejiang University
Last Modified on28 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Sjogren's Syndrome with positive CD19/BCMA expression , and the conventional treatment is not effective and (or) no effective treatment 2. Estimated survival time> 12 weeks; 3. Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up; 4. Patients or their legal guardians volunteer to participate in the study and sign the informed consent

Exclusion Criteria

Subjects with any of the following exclusion criteria were not eligible for this
trial
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
Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis)
Active infection of hepatitis B virus or hepatitis C virus
Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids
Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl
Other uncontrolled diseases that were not suitable for this trial
Patients with HIV infection
Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
Platelets 3010E9/L, and absolute lymphocyte count 1.010E9/L
Methylprednisolone (maximum dose 1mg/kg) or prednisone (maximum dose 1.25mg/kg) instead of immunosuppressive agents to control the disease
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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