Autoimmune Diseases Clinical Trial
Official title:
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome
Status | Recruiting |
Enrollment | 9 |
Est. completion date | November 5, 2024 |
Est. primary completion date | November 5, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 1. 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: 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; 4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids; 7. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; 8. Other uncontrolled diseases that were not suitable for this trial; 9. Patients with HIV infection; 10. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study 11. Platelets =30×10E9/L, and absolute lymphocyte count =1.0×10E9/L 12. Methylprednisolone (maximum dose 1mg/kg) or prednisone (maximum dose 1.25mg/kg) instead of immunosuppressive agents to control the disease. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Zhejiang University | Yake Biotechnology Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting toxicity (DLT) | Adverse events assessed according to NCI-CTCAE v5.0 criteria | Baseline up to 28 days after CD19/BCMA CAR T-cells infusion | |
Primary | Incidence of treatment-emergent adverse events (TEAEs) | Incidence of treatment-emergent adverse events [Safety and Tolerability] | Up to 90 days after CD19/BCMA CAR T-cells infusion | |
Secondary | Concentration of CAR-T cells | In peripheral blood and bone marrow | From admission to the end of the follow-up, up to 2 years | |
Secondary | Objective Response Rate, ORR | Proportion of subjects with complete or partial remission | In 3 months of CD19/BCMA CAR-T cell infusion | |
Secondary | Disease control rate, DCR | The percentage of patients with remission and stable disease after treatment in the total evaluable cases. | From Day 28 CD19/BCMA CAR-T infusion up to 2 years | |
Secondary | Duration of remission, DOR | The time from the first assessment of remission or partial remission of the disease to the first assessment of disease progression or death from any cause | 24 months post CD19/BCMA CAR-T cells infusion | |
Secondary | Progression-free survival, PFS | The time from cell reinfusion to the first assessment of disease progression or death from any cause | 24 months post CD19/BCMA CAR-Tcells infusion | |
Secondary | Overall survival, OS | The time from the cell reinfusion to death due to any cause | From CD19/BCMA CAR-T infusion to death,up to 2 years |
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