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A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)

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Trial Profile

A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 29 Mar 2024

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At a glance

  • Drugs Lisocabtagene-maraleucel (Primary)
  • Indications B-cell lymphoma; CNS cancer; Diffuse large B cell lymphoma; Follicular lymphoma; Mantle-cell lymphoma; Non-Hodgkin's lymphoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms TRANSCEND; TRANSCEND NHL 001
  • Sponsors Juno Therapeutics

    • Most Recent Events

    • 30 Jan 2024 According to a Bristol-Myers Squibb media release, the FDA has accepted two supplemental Biologics License Applications for Breyanzito with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor (BTKi). The FDA has granted both applications Priority Review and assigned a Prescription Drug User Fee Act goal date of May 23, 2024 for Breyanzi in FL and May 31, 2024 for Breyanzi in MCL.
    • 12 Dec 2023 Results assessing evaluation of T-Cell metabolic state presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 12 Dec 2023 Results assessing the outcomes in pts with R/R MCL from prespecified subgroup analyses based on high-risk disease features, were presented at the 65th American Society of Hematology Annual Meeting and Exposition.
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