EMEA-002909-PIP01-20 - paediatric investigation plan

autologous CD4+ and CD8+ T cells genetically modified with a lentiviral vector encoding a B cell maturation antigen-specific chimeric antigen receptor (JCARH125)

Key facts

• Active substance:
  autologous CD4+ and CD8+ T cells genetically modified with a lentiviral vector encoding a B cell maturation antigen-specific chimeric antigen receptor (JCARH125)
• Therapeutic area:
  Oncology
• Decision number:
  P/0082/2021
• PIP number:
  EMEA-002909-PIP01-20
• Pharmaceutical form(s):
  Dispersion for injection
• Condition(s) / indication(s):
  Treatment of mature B cell neoplasms
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  19/03/2021
• Compliance check done:
  No

Decision

P/0082/2021 : EMA decision of 19 March 2021 on the granting of a product specific waiver for autologous CD4+ and CD8+ T cells genetically modified with a lentiviral vector encoding a B cell maturation antigen-specific chimeric....(EMEA-002909-PIP01-20)

Adopted Reference Number: EMA/84238/2021