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New treatment option for Lupus Nephritis
Official title CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
ClinicalTrials.gov ID: NCT06785519
What this study is testing
What is CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection?
CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus nephritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 5\. Expected survival \>12 weeks;
You likely can't join if
- 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...
- 6\. Have used any gene therapy products before;
See the full eligibility 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...
- 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...
- 7\. Volunteer to participate in this experiment and sign the informed consent.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.