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Ciltacabtagene autoleucel - Janssen Biotech/Nanjing Legend Biotech

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Drug Profile

Ciltacabtagene autoleucel - Janssen Biotech/Nanjing Legend Biotech

Alternative Names: BCMA CAR-T - Janssen Biotech; BCMA CAR-T cell therapy- Janssen Biotech/Nanjing Legend Biotech; CAR-T cell therapy - Nanjing; CARVYKTI; cilta-cel; JNJ 4528; JNJ-68284528; LCAR-B38M; LCAR-B38M CAR-T cell therapy; LCARB38M/JNJ-4528

Latest Information Update: 07 Oct 2025

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At a glance

  • Originator Legend Biotech USA; Nanjing Legend Biotech
  • Developer Janssen Biotech; Legend Biotech USA; Nanjing Legend Biotech
  • 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 - Multiple myeloma
  • New Molecular Entity No

Highest Development Phases

  • Marketed Multiple myeloma
  • Phase II Smoldering multiple myeloma

Most Recent Events

  • 07 Oct 2025 Washington University School of Medicine plans a phase I trial for Multiple myeloma (Second line therapy or greater) in USA (IM) in January 2026 (NCT07200089)
  • 03 Oct 2025 Phase-II clinical trials in Multiple myeloma (Combination therapy) in Spain (IV) (NCT07149857)
  • 02 Sep 2025 Janssen Research & Development plans a phase II trial for Multiple Myeloma (Combination therapy) in Unknown location (IV, Infusion) in September 2025 (NCT07149857)

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