AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingEARLY Phase 1Ages 18 Years - anyAllHe Huang
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 1\. Age โ‰ฅ18 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 โ‰ฅ8 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.
๐Ÿ’Š

What it tests

  • CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection
๐Ÿ“

Where

1 site
The first affiliated hospital of medical college of zhejiang university
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy