EMEA-003264-PIP01-22 - paediatric investigation plan

adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z (ARI-0001

Key facts

• Active substance:
  adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z (ARI-0001
• Therapeutic area:
  Oncology
• Decision number:
  P/0225/2023
• PIP number:
  EMEA-003264-PIP01-22
• Pharmaceutical form(s):
  Dispersion for infusion
• Condition(s) / indication(s):
  Treatment of B-lymphoblastic leukaemia/lymphoma
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/06/2023
• Compliance check done:
  No

Decision

P/0225/2023 : EMA decision of 14 June 2023 on agreement of PIP and on granting of deferral and waiver for adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express achimeric antigen ...

Reference Number: EMA/235584/2023