Study Description

Brief summary:

This is a global Phase 2, open-label, single-arm, multicohort, multicenter 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.

• Condition or Disease:Lymphoma, Non-Hodgkin
• Intervention/Treatment: Drug: Fludarabine
  Drug: Cyclophosphamide
  Drug: JCAR017
• Phase: Phase 2

Detailed Description

N/A

Study Design

Arms and interventions

Outcome Measures

• Primary Outcome Measures: 1. Overall Response Rate (ORR) [ Time Frame: Up to 24 months ]
  Is defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) at any time up to 24 months after JCAR017 treatment as assessed by PET-CT and/or CT using "The Lugano classification"
• Secondary Outcome Measures: 1. Complete response rate (CRR) as assessed but PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 24 months ]
  Is defined as the percentage of subjects achieving a CR at any time up to 24 months after JCAR017 treatment
• Secondary Outcome Measures: 2. Duration of Response (DOR) if Best Overall Response (BOR) is CR, as assessed by PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 24 months ]
  is defined for subjects with a BOR of CR as the time from first response (CR or PR) to disease progression or death from any cause up to 24 months after JCAR017 treatment
• Secondary Outcome Measures: 3. Duration of Response (DOR) as assessed by PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 24 months ]
  is defined as the time from first response (CR or PR) to disease progression or death from any cause, whichever occurs first up to 24 months after JCAR017 treatment
• Secondary Outcome Measures: 4. Progression-Free Survival (PFS) as assessed by PET-CT and/or CT using "The Lugano Classification" [ Time Frame: Up to 24 months ]
  is defined as the time from start of JCAR017 to disease progression or death from any cause, whichever occurs first up to 24 months after JCAR017 treatment
• Secondary Outcome Measures: 5. Overall Survival (OS) [ Time Frame: Up to 24 months ]
  is defined as the time from start of JCAR017 to time of death due to any cause up to 24 months after JCAR017 treatment
• Secondary Outcome Measures: 6. Adverse Events (AEs) [ Time Frame: Up to 24 months ]
  An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
• Secondary Outcome Measures: 7. Pharmacokinetics - Cmax [ Time Frame: Up to 24 months ]
  Maximum concentration
• Secondary Outcome Measures: 8. Pharmacokinetics - Tmax [ Time Frame: Up to 24 months ]
  Time to maximum concentration
• Secondary Outcome Measures: 9. Pharmacokinetics - AUC [ Time Frame: Up to 24 months ]
  Area under the curve
• Secondary Outcome Measures: 10. European Organization for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC QLQ-C30) [ Time Frame: Up to 24 months ]
  is questionnaire that will be used as a measure of health-related quality of life. The EORTC QLQ-C30 is composed of both multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/health-related quality of life (HRQoL) scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.
• Secondary Outcome Measures: 11. Functionality Assessment of Cancer Therapy Lymphoma Subscale (FACT-LymS) [ Time Frame: Up to 24 months ]
  is a 15-item lymphoma-specific additional concerns subscale. This subscale addresses symptoms and functional limitations are important to lymphoma patients. The FACT-LymS items are scored on a 0 ("Not at all") to 4 ("Very much") response scale. Items are aggregated to a single score on a 0-60 scale. High scores indicate lower symptom burden.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.

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• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

More Information

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT04245839 History of Changes
• Other Study ID Numbers: JCAR017-FOL-001, U1111-1244-9768, 2019-004081-18
• First Posted: January 29, 2020 Key Record Dates
• Last Update Posted: August 9, 2021
• Last Verified: July 2021

• Individual Participant
  Data (IPD) Sharing
  Statement:

• Plan to Share IPD: Yes
• Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
• Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
• Time Frame: See Plan Description
• Access Criteria: See Plan Description
• URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Celgene: Relapsed or Refractory
  JCAR017 B-cell Non-Hodgkin Lymphoma (NHL)
• Additional relevant MeSH terms: Lymphoma, B-Cell
  Lymphoma, Non-Hodgkin Lymphoma