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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: 12 Mar 2025

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At a glance

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

    • Most Recent Events

    • 03 Sep 2024 According to Imugene media release, for cohort A: 6 and for cohort B: 4 patients were treated now the company will continue to enroll additional patients in Cohort B and the company aims to provide an interim Phase 1b data update.
    • 03 Sep 2024 Results presented in the Imugene Media Release.
    • 03 Jul 2024 Planned End Date changed from 1 Mar 2028 to 1 Jun 2027.

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