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)

• 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