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Multicenter, Open-label, Adaptive Design Phase I Trial With Genetically Modified T-cells Carrying Universal Chimeric Antigen Receptors (UniCAR02-T) in Combination With CD123 Target Module (TM123) for the Treatment of Patients With Hematologic and Lymphatic Malignancies Positive for CD123

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Trial Profile

Multicenter, Open-label, Adaptive Design Phase I Trial With Genetically Modified T-cells Carrying Universal Chimeric Antigen Receptors (UniCAR02-T) in Combination With CD123 Target Module (TM123) for the Treatment of Patients With Hematologic and Lymphatic Malignancies Positive for CD123

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 01 Apr 2025

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At a glance

  • Drugs AVC-101 (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Acute myeloid leukaemia; Blastic plasmacytoid dendritic cell neoplasm; Precursor B-cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors AvenCell Europe; Cellex Patient Treatment

Most Recent Events

  • 25 Mar 2025 Status changed from recruiting to active, no longer recruiting.
  • 11 Feb 2025 Treatment assignment changed from sequential to parallel, hence the protocol, was amended.
  • 29 May 2024 Number of treatment arms are increased from 1 to 2 by the addition of a new arm for 8 mg/day TM123, thus the study design becomes randomized.

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