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Активно (без набиране) Фаза 2 2024-514006-31-00

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)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Non-active Progressive Multiple Sclerosis (PMS)

Спонсор: Novartis Pharma AG

Налично на: БГ
Обобщение
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.
Описание
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).
Кой може да участва
Age group: 18-64 years Gender: Female, Male Target enrollment: 18 participants
Интервенции
YTB323
Drug
CYCLOPHOSPHAMIDE
Drug
FLUDARABINE PHOSPHATE
Drug
TOCILIZUMAB
Drug
Места на провеждане 4
Франция (1)
Германия (1)
Италия (1)
Испания (1)
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
64 Years
Здрави доброволци
Не
Начална дата
22.04.2025
Регистрационен номер
2024-514006-31-00
Източник
euclinicaltrials.eu
Запитване за медицински туризъм

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