Systemic Lupus Erythematosus., Lupus Nephritis
Conditions
Brief summary
Safety parameters include vital signs, adverse events, laboratory parameters and ECG evaluation.
Detailed description
YTB323 transgene concentration by qPCR over time in peripheral blood; cellular kinetics parameters (Cmax, AUC, Tmax, T1/2, Clast, Tlast)., Pre-existing and treatment induced immunogenicity (cellular, humoral) of YTB323., Manufacture success (defined as meeting release specification and at or above the planned target dose)., At various timepoints: - SLEDAI-2K - Physician's global assessment - LLDAS - Remission (DORIS), UPCR at various timepoints., Complete Renal Response (CRR) at various timepoints.
Interventions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| YTB323 transgene concentration by qPCR over time in peripheral blood; cellular kinetics parameters (Cmax, AUC, Tmax, T1/2, Clast, Tlast)., Pre-existing and treatment induced immunogenicity (cellular, humoral) of YTB323., Manufacture success (defined as meeting release specification and at or above the planned target dose)., At various timepoints: - SLEDAI-2K - Physician's global assessment - LLDAS - Remission (DORIS), UPCR at various timepoints., Complete Renal Response (CRR) at various timepoints. | — |
Primary
| Measure | Time frame |
|---|---|
| Safety parameters include vital signs, adverse events, laboratory parameters and ECG evaluation. | — |
Countries
France, Germany, Spain
Outcome results
None listed