Relapsing Multiple Sclerosis
Conditions
Brief summary
Change in safety parameters including, but not limited to severity and frequency dose limiting toxicities (DLTs) of Adverse Events (AEs) and findings in vital signs, laboratory, ECG, neurological status, and safety MRIs of the brain and spinal cord
Detailed description
Clinical measures for relapses and disability (includes EDSS, XX, T25FW, 9HPT, SDMT, XX) and MRI changes in disease activity (including new and enlarging T2 lesions and Gd-enhancing T1 lesions), YTB323 transgene expression levels by qPCR over time in blood; cellular kinetics parameters (Cmax, AUC, Tmax, Clast, Tlast), Safety data from each dose level, Pre-existing and treatment-induced immunogenicity (humoral, anti-YTB323 antibody; and cellular, presence of CAR19 specific CD4 and CD8 T cells measuring interferon gamma production)
Interventions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in safety parameters including, but not limited to severity and frequency dose limiting toxicities (DLTs) of Adverse Events (AEs) and findings in vital signs, laboratory, ECG, neurological status, and safety MRIs of the brain and spinal cord | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical measures for relapses and disability (includes EDSS, XX, T25FW, 9HPT, SDMT, XX) and MRI changes in disease activity (including new and enlarging T2 lesions and Gd-enhancing T1 lesions), YTB323 transgene expression levels by qPCR over time in blood; cellular kinetics parameters (Cmax, AUC, Tmax, Clast, Tlast), Safety data from each dose level, Pre-existing and treatment-induced immunogenicity (humoral, anti-YTB323 antibody; and cellular, presence of CAR19 specific CD4 and CD8 T cells measuring interferon gamma production) | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed