Lupus Nephritis
Conditions
Keywords
CD19/BCMA CAR-T
Brief summary
A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.
Detailed description
In this study, 9 patients with relapsed refractory Lupus Nephritis were proposed to undergo CD19/BCMA CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19/BCMA CAR-T Cells therapy for relapsed refractory Lupus Nephritis; At the same time, on the basis of expanding the sample size, more safety data on CD19/BCMA CAR-T Cells treatment for relapsed refractory Lupus Nephritis were accumulated.
Interventions
BIOLOGICALCD19/BCMA Lupus Nephritis Targeted CAR T-cells injection
Each subject receive CD19/BCMA Lupus Nephritis Targeted CAR T-cells by intravenous infusion
Sponsors
Yake Biotechnology Ltd.
He Huang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | Up to 28 years after Treatment | Adverse events assessed according to NCI-CTCAE v5.0 criteria |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 2 years after Treatment | Incidence of treatment-emergent adverse events \[Safety and Tolerability\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary protein index | Up to 24 hours after Treatment | Urinary protein index（24h urinary protein、Urinary protein/creatinine ratio） |
Countries
China
Contacts
Primary ContactHe Huang, MD
Backup ContactYongxian Hu, MD
Outcome results
None listed