A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Duvortuxizumab, A Humanized CD19 x CD3 Dual-Affinity Re-Targeting (DART®) Protein in Subjects With Relapsed or Refractory B-cell Malignancies

Trial Profile

A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Duvortuxizumab, A Humanized CD19 x CD3 Dual-Affinity Re-Targeting (DART®) Protein in Subjects With Relapsed or Refractory B-cell Malignancies

Recruiting
Phase of Trial: Phase I

Latest Information Update: 27 Apr 2017

At a glance

  • Drugs Duvortuxizumab (Primary)
  • Indications Acute lymphoblastic leukaemia; B cell lymphoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 21 Apr 2017 Planned number of patients changed from 221 to 220.
    • 21 Apr 2017 Planned End Date changed from 21 Oct 2019 to 29 Jan 2021.
    • 21 Apr 2017 Planned primary completion date changed from 18 Oct 2017 to 21 Jan 2020.
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