A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

Titre officiel

A Phase 2, Open-label, Single Arm, Multicentre Trial to Evaluate the Safety and Efficacy of JCAR017 (Lisocabtagene Maraleucel) in Adult Subjects With High-risk, Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

Sommaire:

This is a global Phase 2, open-label, single-arm, multicohort, multicentre study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL. The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This study is divided into three periods: - Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation; - Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29; - Posttreatment, which includes follow-up assessments for disease status and safety for 2 years.

Description de l'essai

Primary Outcome:

  • Complete Response Rate (CRR)
Secondary Outcome:
  • Overall response rate (ORR) as assessed by PET-CT and/or CT using "The Lugano Classification"
  • Duration of response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification"
  • Duration of response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification"
  • Progression-free survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification"
  • Overall Survival (OS)
  • Adverse Events (AEs)
  • Pharmacokinetics - Cmax
  • Pharmacokinetics - Tmax
  • Pharmacokinetics - AUC
  • European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30)
  • Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS)

Voir cet essai sur ClinicalTrials.gov

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