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Phase 1/1b, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate Safety and Clinical Activity of PBCAR0191 (azercabtagene Zapreleucel or "azer-cel") in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and R/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

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Trial Profile

Phase 1/1b, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate Safety and Clinical Activity of PBCAR0191 (azercabtagene Zapreleucel or "azer-cel") in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and R/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 17 Aug 2025

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At a glance

  • Drugs Azercabtagene zapreleucel (Primary) ; Cyclophosphamide; Fludarabine; Interleukin-2
  • Indications B-cell lymphoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Marginal zone B-cell lymphoma; Non-Hodgkin's lymphoma; Precursor B-cell lymphoblastic leukaemia-lymphoma; Waldenstrom's macroglobulinaemia
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Imugene; Precision Biosciences

Most Recent Events

  • 17 Jul 2025 Results presented in an Imugene media release.
  • 15 Jul 2025 Results presented in an Imugene media release.
  • 14 Jul 2025 According to Imugene media release, the company continues to actively enrol patients into the Phase 1b azer-cel trial at ten US sites with up to six sites in Australia planned, after the first Australian patient was dosed in January 2025 at Royal Prince Alfred Hospital in Sydney, resulting in a Complete Response.

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