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Rondecabtagene autoleucel - ImmPACT Bio

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Drug Profile

Rondecabtagene autoleucel - ImmPACT Bio

Alternative Names: CD19-CD20 bi-specific CAR-T - ImmPACT Bio; CD19-CD20 bi-specific chimeric antigen receptor-T cell therapy - ImmPACT Bio; IMPT-314; LYL 314; Ronde-cel

Latest Information Update: 29 Oct 2025

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At a glance

  • Originator ImmPACT Bio
  • Developer ImmPACT Bio; Lyell Immunopharma
  • Class Antineoplastics; CAR-T cell therapies; Gene therapies; Immunotherapies
  • Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase III B-cell lymphoma
  • Phase I Chronic lymphocytic leukaemia

Most Recent Events

  • 23 Sep 2025 Lyell Immunopharma plans phase III PiNACLE-H2H trial for B-cell Lymphoma (Second-line therapy or greater) (Parenteral) in January 2026 (NCT07188558)
  • 03 Sep 2025 Phase-III clinical trials in B-cell lymphoma (Second-line therapy or greater) in USA, Australia (IV, Infusion) (NCT07188558)
  • 17 Jun 2025 Efficacy and adverse events data from phase I/II clinical trials in Non-Hodgkin's lymphoma released by Lyell Immunopharma

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