CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
ConditionLupus Nephritis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHe Huang
About this trial
A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
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);
Trial design
Design model
Single group
Treatments tested in this trial
CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection
Biological/VaccineEach subject receive CD19/BCMA Lupus Nephritis Targeted CAR T-cells by intravenous infusion
Treatment groups
9 Participants
are divided into 1 treatment groupGroup A: Lupus NephritisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame
Up to 28 years after Treatment2
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame
Up to 2 years after TreatmentSecondary outcomes
1
Urinary protein index
Urinary protein index（24h urinary protein、Urinary protein/creatinine ratio）
Time frame
Up to 24 hours after TreatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov