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Active (not recruiting) Phase 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)

Phase 2 – studying effectiveness and dosage
Conditions: Non-active Progressive Multiple Sclerosis (PMS)

Sponsor: Novartis Pharma AG

trial.available_in: БГ
Overview
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
Interventions
YTB323
Drug
CYCLOPHOSPHAMIDE
Drug
FLUDARABINE PHOSPHATE
Drug
TOCILIZUMAB
Drug
Locations 4
France (1)
Germany (1)
Italy (1)
Spain (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
64 Years
Healthy volunteers
No
Start date
22.04.2025
Registry ID
2024-514006-31-00
Source
euclinicaltrials.eu
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