CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis

He Huang

Status and phase

Enrolling

Early Phase 1

Conditions

Lupus Nephritis

Treatments

Biological: CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06785519

TXB2024012

Details and patient eligibility

About

A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.

Full description

In this study, 9 patients with relapsed refractory Lupus Nephritis were proposed to undergo CD19/BCMA CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19/BCMA CAR-T Cells therapy for relapsed refractory Lupus Nephritis; At the same time, on the basis of expanding the sample size, more safety data on CD19/BCMA CAR-T Cells treatment for relapsed refractory Lupus Nephritis were accumulated.

Enrollment

9 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old;
1. A clinical diagnosis of systemic lupus erythematosus (SLE) according to the 2019 American College of Rheumatology (ACR) and European Federation of Rheumatology Societies (EULAR) /ACR classification criteria. Grade III, IV, or V lupus nephritis was confirmed by biopsy according to the 2003 ISN/RPS standard.
1. SLEDAI-2K ≥8 during screening
1. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);
1. Expected survival >12 weeks;
1. Fertile women and men agree to use appropriate contraceptive methods before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known);
1. Volunteer to participate in this experiment and sign the informed consent.

Exclusion criteria

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
1. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
1. Active infected persons who are not cured:
1. Active hepatitis B or C virus infection;
1. Patients who have taken more than 20mg/d of prednisone or equivalent systemic steroid drugs within 1 week prior to treatment (except those who have recently or currently taken inhaled steroids);
1. Have used any gene therapy products before;
1. Insufficient amplification ability (<5 times) in response to CD3 / CD28 costimulation signals;
1. ALT/AST>3 times the normal amount or bilirubin >2.0 mg/dl;
1. Those who have other uncontrolled diseases that the researcher deems unsuitable for enrollment;
1. HIV-infected people;
1. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.