NCT06785519 CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
| NCT ID | NCT06785519 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | He Huang |
| Condition | Lupus Nephritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2025-01-31 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 9 participants in total. It began in 2025-01-31 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.
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.
Contact & Investigator
He Huang, MD
PRINCIPAL INVESTIGATOR
Zhejiang University
Frequently Asked Questions
Who can join the NCT06785519 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lupus Nephritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06785519 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06785519 currently recruiting?
Yes, NCT06785519 is actively recruiting participants. Contact the research team at hehuangyu@126.com for enrollment information.
Where is the NCT06785519 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06785519 clinical trial?
NCT06785519 is sponsored by He Huang. The principal investigator is He Huang, MD at Zhejiang University. The trial plans to enroll 9 participants.
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