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A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO3, a CAR T Cell Treatment Targeting CD19 and CD22 in Paediatric and Young Adult Patients with Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia

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Trial Profile

A Single Arm, Open-Label, Multi-Centre, Phase I/II Study Evaluating the Safety and Clinical Activity of AUTO3, a CAR T Cell Treatment Targeting CD19 and CD22 in Paediatric and Young Adult Patients with Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 01 Mar 2023

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At a glance

  • Drugs AUTO-3 (Primary) ; Cyclophosphamide; Fludarabine; Pembrolizumab
  • Indications Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms AMELIA
  • Sponsors Autolus
  • Most Recent Events

    • 23 Feb 2023 Results (n=52; data cut Feb 28, 2022) assessing safety and efficacy of CD19/22 dual-targeting CAR-T (AUTO3) plus pembrolizumab in relapsed/refractory large B cell lymphoma as inpatient or outpatient therapy, published in the Blood.
    • 01 Oct 2021 Results (n=15; data cut-off 1 June 2020) assessing pre-clinical experiments with AUTO3 together with the safety and efficacy results of this phase 1 clinical trial, published in the Nature Medicine.
    • 13 Jul 2020 Status changed from active, no longer recruiting to completed.

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