A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Immune Nephritis

Zhejiang University

Status and phase

Enrolling

Early Phase 1

Conditions

Immune Nephritis

Lupus Nephritis

Autoimmune Diseases

Treatments

Biological: Assigned Interventions CD19/BCMA CAR T-cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05085418

CD19/BCMA-004

Details and patient eligibility

About

A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Immune Nephritis

Full description

Immune nephritis is a chronic glomerular disease originating in the kidney caused by various etiologies.Clinically, secondary chronic kidney damage caused by systemic diseases such as diabetes, systemic lupus erythematosus and gout is named after its primary disease, such as diabetic nephropathy and lupus nephritis. 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.

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.

Enrollment

9 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Immune Nephritis 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.