Last updated: October 11, 2021
Sponsor: Zhejiang University
Overall Status: Active - Recruiting
Phase
1
Condition
Sjogren's Syndrome
Connective Tissue Diseases
Dermatomyositis (Connective Tissue Disease)
Treatment
N/AClinical Study ID
NCT05085431
CD19/BCMA-003
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Sjogren's Syndrome with positive CD19/BCMA expression , and the conventionaltreatment 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 ofadministration and agreed to take effective contraceptive measures during the testperiod until the last follow-up; 4. Patients or their legal guardians volunteer toparticipate in the study and sign the informed consent.
Exclusion
Exclusion Criteria:
- Subjects with any of the following exclusion criteria were not eligible for thistrial:
- History of craniocerebral trauma, conscious disturbance, epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such assevere arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infectionand 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>2.0mg/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 patientsor interfere with the results of study
- Platelets ≥30×10E9/L, and absolute lymphocyte count ≥1.0×10E9/L
- Methylprednisolone (maximum dose 1mg/kg) or prednisone (maximum dose 1.25mg/kg)instead of immunosuppressive agents to control the disease.
Study Design
Total Participants: 9
Study Start date:
November 05, 2021
Estimated Completion Date:
November 05, 2024
Study Description
Connect with a study center
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting

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