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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05085431
Other study ID # CD19/BCMA-003
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date November 5, 2021
Est. completion date November 5, 2024

Study information

Verified date October 2021
Source Zhejiang University
Contact He Huang, PhD
Phone 86-13605714822
Email hehuangyu@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China The First Affiliated Hospital, College of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (2)

Lead Sponsor Collaborator
Zhejiang University Yake Biotechnology Ltd.

Country where clinical trial is conducted

China, 

Outcome

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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