An open-label, multi-center, phase I/II study to assess safety, disease progression, and cellular kinetics following YTB323 administration in participants with non-active Progressive Multiple Sclerosis (PMS)
Trial status: Authorised
Change from baseline for clinical measures of disability (includes EDSS, T25FW, 9HPT, SDMT)., 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).
Occurrence, severity and frequency of dose limiting toxicities (DLTs), Adverse Events (AEs) and change from baseline over 2 years in safety parameters including, but not limited to vital signs, laboratory, ECG, neurological status, and safety measures from brain and spinal cord MRIs.
Description
Change from baseline for clinical measures of disability (includes EDSS, T25FW, 9HPT, SDMT)., 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).
Who can participate
Age group: 18-64 years
Gender: Female, Male
Target enrollment: 18 participants