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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: 18 Jun 2026

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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.

    Yes - B-cell lymphoma
  • New Molecular Entity No

Highest Development Phases

  • Phase III B-cell lymphoma
  • Phase I/II Non-Hodgkin's lymphoma
  • No development reported Chronic lymphocytic leukaemia

Most Recent Events

  • 12 Jun 2026 Adverse events and pharmacodynamics data from phase I/II trial in Non-Hodgkin's lymphoma released by ImmPACT Bio
  • 12 Feb 2026 Lyell Immunopharma announces intention to submit BLA to US FDA for B-cell lymphoma (Second-line therapy or greater) in 2027
  • 12 Feb 2026 Rondecabtagene autoleucel - ImmPACT Bio receives Orphan Drug status for B-cell lymphoma in USA

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