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A Phase 2/3 Randomized, Placebo-Controlled, Multi-Center Trial of Lenzilumab to Improve the Safety and Efficacy of CAR-T Cell Therapy in Adults with Relapsed or Refractory Large B-Cell Lymphoma

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Trial Profile

A Phase 2/3 Randomized, Placebo-Controlled, Multi-Center Trial of Lenzilumab to Improve the Safety and Efficacy of CAR-T Cell Therapy in Adults with Relapsed or Refractory Large B-Cell Lymphoma

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 12 May 2022

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At a glance

  • Drugs Anti-CD19 CAR-transduced T cells (Primary) ; Axicabtagene ciloleucel (Primary) ; Lenzilumab (Primary)
  • Indications Diffuse large B cell lymphoma; Non-Hodgkin's lymphoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SHIELD
  • Sponsors Humanigen

    • Most Recent Events

    • 05 May 2022 According to a Humanigen media release, the company gained alignment with the FDA on the protocol for this study, in which the company intends to enroll the first patient in the second quarter.
    • 20 Apr 2022 According to a Humanigen media release, the company expect to initiate this trial in the 1H22.
    • 28 Feb 2022 According to a Humanigen media release, the company plans on initiating the SHIELD Phase 3 registrational CAR-T study in the US in 2022.

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