CAR-T Cell Therapy for Lupus Nephritis

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

This study is testing a new CAR-T cell therapy to see if it can help people with tough-to-treat lupus nephritis feel better.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhejiang University (Academic / other)
• Drugs / interventions: prednisone, CAR-T
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06785519 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of CD19/BCMA CAR-T cell therapy in patients with refractory or relapsed lupus nephritis. A total of 9 patients diagnosed with systemic lupus erythematosus and confirmed lupus nephritis will receive targeted CAR-T cell injections. The study aims to gather more safety data and assess the effectiveness of this innovative treatment approach. Participants will be closely monitored for their response to the therapy and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of systemic lupus erythematosus and confirmed lupus nephritis who have not responded to standard treatments.

Not a fit: Patients with a history of severe neurological conditions or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients suffering from refractory lupus nephritis.

How similar studies have performed: While CAR-T cell therapy has shown promise in other conditions, this specific application for lupus nephritis is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 1\. Age ≥18 years old;
* 2\. 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.
* 3\. SLEDAI-2K ≥8 during screening
* 4\. failure to respond to two or more standard immunosuppressive therapies, or relapse (increased disease activity index and need to adjust drug dose or type);
* 5\. Expected survival \>12 weeks;
* 6\. 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);
* 7\. 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;
* 2\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
* 3\. Active infected persons who are not cured:
* 4\. Active hepatitis B or C virus infection;
* 5\. 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);
* 6\. Have used any gene therapy products before;
* 7\. Insufficient amplification ability (\<5 times) in response to CD3 / CD28 costimulation signals;
* 8\. ALT/AST\>3 times the normal amount or bilirubin \>2.0 mg/dl;
* 9\. Those who have other uncontrolled diseases that the researcher deems unsuitable for enrollment;
* 10\. HIV-infected people;
* 11\. Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.

Where this trial is running

Hangzhou, Zhejiang

• The first affiliated hospital of medical college of zhejiang university — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: He Huang, MD — Zhejiang University
• Study coordinator: He Huang, MD

Conditions Lupus Nephritis; CD19/BCMA CAR-T