A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome
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|ClinicalTrials.gov Identifier: NCT05085431|
Recruitment Status : Recruiting
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Sjogren's Syndrome Autoimmune Diseases||Biological: Assigned Interventions CD19/BCMA CAR T-cells||Early Phase 1|
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. Sjögren'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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome|
|Estimated Study Start Date :||November 5, 2021|
|Estimated Primary Completion Date :||November 5, 2024|
|Estimated Study Completion Date :||November 5, 2024|
Experimental: Treatment of Sjogren's Syndrome
Experimental：Administration of CD19/BCMA CAR T-cells A dose levels of 1-4*10E6/kg are administrated for each subject.
Biological: Assigned Interventions CD19/BCMA CAR T-cells
Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection
- Dose-limiting toxicity (DLT) [ Time Frame: Baseline up to 28 days after CD19/BCMA CAR T-cells infusion ]Adverse events assessed according to NCI-CTCAE v5.0 criteria
- Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 90 days after CD19/BCMA CAR T-cells infusion ]Incidence of treatment-emergent adverse events [Safety and Tolerability]
- Concentration of CAR-T cells [ Time Frame: From admission to the end of the follow-up, up to 2 years ]In peripheral blood and bone marrow
- Objective Response Rate, ORR [ Time Frame: In 3 months of CD19/BCMA CAR-T cell infusion ]Proportion of subjects with complete or partial remission
- Disease control rate, DCR [ Time Frame: From Day 28 CD19/BCMA CAR-T infusion up to 2 years ]The percentage of patients with remission and stable disease after treatment in the total evaluable cases.
- Duration of remission, DOR [ Time Frame: 24 months post CD19/BCMA CAR-T cells infusion ]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
- Progression-free survival, PFS [ Time Frame: 24 months post CD19/BCMA CAR-Tcells infusion ]The time from cell reinfusion to the first assessment of disease progression or death from any cause
- Overall survival, OS [ Time Frame: From CD19/BCMA CAR-T infusion to death，up to 2 years ]The time from the cell reinfusion to death due to any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05085431
|Contact: He Huang, PhDemail@example.com|
|Contact: Yongxian Hu, PhDfirstname.lastname@example.org|
|Principal Investigator:||He Huang, PhD||First Affiliated Hospital of Zhejiang University|