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CLN 049

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Drug Profile

CLN 049

Alternative Names: CLN-049

Latest Information Update: 06 Aug 2026

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At a glance

  • Originator German Cancer Research Center; University of Tubingen
  • Developer Cullinan Florentine; Cullinan Therapeutics
  • Class Antineoplastics; Bispecific antibodies; Immunotherapies; Recombinant fusion proteins
  • Mechanism of Action Antibody-dependent cell cytotoxicity; Cytotoxic T lymphocyte stimulants; Immunologic cytotoxicity
  • Orphan Drug Status

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

    Yes - Acute myeloid leukaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I Acute myeloid leukaemia; Myelodysplastic syndromes

Most Recent Events

  • 29 Jul 2026 US FDA recommends positive feedback in End-of-Phase 1 meeting of CLN 049 for Acute myeloid leukemia in USA
  • 28 Jul 2026 Cullinan Therapeutics plans a phase II trial for Acute myeloid leukaemia (Second-line therapy or greater) in the third quarter of 2026
  • 23 Jul 2026 Cullinan Therapeutics plans a phase I/II trial for Acute myeloid leukemia (Combination therapy, First line therapy) in the US (Parenteral) (NCT07722767)

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