CAR-T Cell Therapy for Lupus Nephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: hehuangyu@126.com
• Phone: 0571-87233772

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TranspoCART19 CAR-T therapy in adults with refractory lupus nephritis

  This trial tests whether a patient’s own CD19 CAR-T cells can be safely given and potentially help adults with lupus nephritis that isn’t responding to standard treatments.

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• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Biomarker-guided CAR-T target selection for refractory lupus

  This trial tests whether using a lab-based immune profile to pick CD19- or BCMA-targeted CAR-T can help adults with refractory lupus, including lupus nephritis, who have not responded to standard treatments.

  Recruiting Phase 1/2 Beijing Biotech · Shenzhen, Guangdong · NCT07523542

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

  This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

  This study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.

  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.