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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: 05 Feb 2026

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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

  • 02 Feb 2026 Planned number of patients changed from 129 to 135.
  • 02 Feb 2026 Planned primary completion date changed from 1 Jun 2025 to 1 Jun 2027.
  • 03 Nov 2025 Results presented in an Imugene media release.

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