LCAR-B38M CAR-T cell therapy - Janssen Biotech/Nanjing Legend Biotech

Drug Profile

LCAR-B38M CAR-T cell therapy - Janssen Biotech/Nanjing Legend Biotech

Alternative Names: CAR-T cell therapy - Nanjing; JNJ 4528; JNJ-68284528; LCAR-B38M

Latest Information Update: 08 Aug 2018

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At a glance

  • Originator Nanjing Legend Biotech
  • Developer Janssen Biotech; Nanjing Legend Biotech
  • Class 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 I/II Multiple myeloma

Most Recent Events

  • 29 Jun 2018 Phase-I/II clinical trials in Multiple myeloma (Second-line therapy or greater) in USA (Injection) (NCT03548207) (EudraCT2018-000121-32)
  • 30 May 2018 The US FDA approves IND application for LCAR-B38M (JNJ 68284528) in Multiple myeloma (Second-line therapy or greater) (9242033; 9242043)
  • 30 May 2018 Janssen Biotech plans a phase Ib/II trial in Multiple myeloma (Second-line therapy or greater) in USA in the second half of 2018
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