EMEA-002823-PIP01-20 - paediatric investigation plan

Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains (CT053)

Key facts

• Active Substance:
  Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains (CT053)
• Therapeutic area:
  Oncology
• Decision number:
  P/0411/2020
• PIP number:
  EMEA-002823-PIP01-20
• Pharmaceutical form(s):
  Suspension for infusion
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  Intravenous use
• Contact for public enquiries:

  CARsgen Therapeutics Corporation

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  23/10/2020

Decision

P/0411/2020 : EMA decision of 23 October 2020 on the granting of a product specific waiver for autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector.......(CT053) (EMEA-002823-PIP01-20)

AdoptedReference Number: EMA/494523/2020