CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
Recruiting now · Early Phase 1
Conditions studied: Lupus Nephritis
In brief
A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.
Key facts
- Study ID
- NCT06785519
- Run by
- He Huang
- People needed
- 9
- Starts
- 2025-01-31
- Expected to finish
- 2027-10-31
- Last updated by the study team
- 2025-01-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 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.
You may not qualify 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 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 is running
- The first affiliated hospital of medical college of zhejiang university — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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