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Phase I, open label, dose-escalation study followed by a safety expansion part to evaluate the safety, expansion and persistence of a single dose of UCART19 (allogeneic engineered T-cells expressing anti-CD19 chimeric antigen receptor), administered intravenously in patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukaemia (B-ALL))

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Trial Profile

Phase I, open label, dose-escalation study followed by a safety expansion part to evaluate the safety, expansion and persistence of a single dose of UCART19 (allogeneic engineered T-cells expressing anti-CD19 chimeric antigen receptor), administered intravenously in patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukaemia (B-ALL))

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 13 Oct 2024

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At a glance

  • Drugs UCART 19 (Primary) ; Alemtuzumab; Cyclophosphamide; Fludarabine
  • Indications Precursor B-cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; First in man
  • Acronyms CALM
  • Sponsors Servier

Most Recent Events

  • 04 Mar 2021 According to a Cellectis media release, pooled results of CALM and PALL studies published in the Lancet journal.
  • 15 Sep 2020 Status changed from recruiting to completed.
  • 07 Sep 2020 This trial has been completed in France (Date of the global end of the trial: 30 July 2020).

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