EMEA-003212-PIP01-22 - paediatric investigation plan

Autologous CD4+ and CD8+ T cells transduced with lentiviral vector encoding a chimeric antigen receptor (CAR) directed against CD19 and preserving the T cell phenotype of the leukapheresis starting material (YTB323)

Key facts

• Active Substance:
  Autologous CD4+ and CD8+ T cells transduced with lentiviral vector encoding a chimeric antigen receptor (CAR) directed against CD19 and preserving the T cell phenotype of the leukapheresis starting material (YTB323)
• Therapeutic area:
  Oncology
• Decision number:
  P/0024/2023
• PIP number:
  EMEA-003212-PIP01-22
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of mature B-cell neoplasms
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  Novartis Europharm Limited

  United Kingdom; Tel. [phone]; Fax [phone]; Email: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  31/01/2024

Decision

P/0024/2023: EMA decision of 31 January 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for autologous CD4+ and CD8+ T cells transduced [..] (EMEA-003212-PIP-22)

AdoptedReference Number: EMA/20605/2023