EMA/PE/0000240548 - paediatric investigation plan

autologous t-cells transduced with a lentiviral vector expressing a chimeric antigen receptor against bcma and gprc5d

Key facts

• Active substance:
  autologous t-cells transduced with a lentiviral vector expressing a chimeric antigen receptor against bcma and gprc5d
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  EMA/PE/0000240548
• PIP number:
  EMA/PE/0000240548
• Pharmaceutical form(s):
  All pharmaceutical forms
• Condition(s) / indication(s):
  Treatment of Multiple Myeloma
• Route(s) of administration:
  All routes of administration
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  16/05/2025
• Compliance check done:
  Nei

Decision

EMA/PE/0000240548 : EMA decision of 16 May 2025 on the granting of a product specific waiver for autologous T-cells transduced with a lentiviral vector expressing a chimeric antigen receptor against BCMA and GPRC5D

Adopted Reference Number: EMADOC-1700519818-2114054