RecruitingEarly Phase 1NCT06785519

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

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

Sponsor

He Huang

Enrollment

9 participants

Start Date

Jan 31, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

\. Age ≥18 years old;
\. 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.
\. SLEDAI-2K ≥8 during screening
\. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);
\. Expected survival >12 weeks;
\. 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);
\. Volunteer to participate in this experiment and sign the informed consent.

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

Interested in this trial?

Get notified about updates and connect with the research team.

BIOLOGICALCD19/BCMA Lupus Nephritis Targeted CAR T-cells injection

Each subject receive CD19/BCMA Lupus Nephritis Targeted CAR T-cells by intravenous infusion

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT06785519