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

  • Clinicaltrials.gov identifier

    NCT04245839

  • Recruitment Status

    Recruiting

  • First Posted

    January 29, 2020

  • Last update posted

    August 9, 2021

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

  • Study Type: Interventional
  • Estimated Enrollment: 188 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase 2, Open-label, Single Arm, Multicenter 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)
  • Actual Study Start Date: July 2020
  • Estimated Primary Completion Date: April 2024
  • Estimated Study Completion Date: April 2024

Arms and interventions

Arm Intervention/treatment
Experimental: Administration of JCAR017
Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents. JCAR017 will be infused on Day 1 at a dose of 100 × 10^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.
Drug: Fludarabine
Fludarabine

Drug: Cyclophosphamide
Cyclophosphamide

Drug: JCAR017
JCAR017

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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 7. Pharmacokinetics - Cmax [ Time Frame: Up to 24 months ]
    Maximum concentration
  • 8. Pharmacokinetics - Tmax [ Time Frame: Up to 24 months ]
    Time to maximum concentration
  • 9. Pharmacokinetics - AUC [ Time Frame: Up to 24 months ]
    Area under the curve
  • 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.
  • 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

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

Criteria

Inclusion Criteria: 1. Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by local pathology 2. Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent 3. Follicular lymphoma patients: Received at least one prior line of systemic therapy. Patients that received one prior line of systemic therapy are eligible if they present with high risk features. Patients that received two or more prior lines of systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2) 4. Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2) or relapsed after hematopoietic stem cell transplant 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Adequate organ function 7. Adequate vascular access for leukapheresis procedure Exclusion Criteria: 1. Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL 2. WHO subclassification of duodenal-type FL 3. Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study) 4. History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies 5. Prior CAR T-cell or other genetically-modified cell therapy 6. History of or active human immunodeficiency virus (HIV) 7. Active hepatitis B or active hepatitis C 8. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment 9. Active autoimmune disease requiring immunosuppressive therapy 10. Presence of acute or chronic graft-versus-host=disease 11. History of significant cardiovascular disease 12. History or presence of clinically relevant central nervous system pathology 13. Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations

United States, California
UCLA Medical Centre-Santa Monica
Santa Monica

United States, Colorado
University of Colorado Cancer Center
Aurora

United States, Connecticut
Yale New Haven Health - Smilow Cancer Hospita
New Haven

United States, Illinois
Northwestern University - Robert H. Lurie Comprehensive Cancer Center
Chicago

United States, Illinois
Illinois Cancer Specialists - Arlington Heights
Niles

United States, Maryland
University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore

United States, Massachusetts
Massachusetts General Hospital - Dana-Farber Cancer Institute (The Jon and JoAnn Hagler Center for Lymphoma)
Boston

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston

United States, New York
Memorial Sloan Kettering Cancer Center
New York

United States, North Carolina
Novant Health Cancer Specialists Charlotte
Charlotte

United States, Ohio
Cleveland Clinic - Taussig Cancer Institute
Cleveland

United States, Oregon
Providence Cancer Center - Earle A. Chiles Research Institute
Portland

United States, Pennsylvania
Perelman Center for Advanced Medicine - Abramson Cancer Center University of Pennsylvania
Philadelphia

United States, South Dakota
Avera Research Institute
Sioux Falls

United States, Texas
The University of Texas - MD Anderson Cancer Center
Houston

United States, Virginia
University of Virginia Health System
Charlottesville

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle

Austria
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien
Wien

Canada, Montreal
Hospital Maisonneuve - Rosemont
Quebec

Canada, Toronto
Princess Margaret Cancer Centre
Ontario

Canada
CIUSSS de l'Est-de-l'Ile-de-Montreal - Installation Hopital Maisonneuve-Rosemont
Quebec

France
CHRU-Hopital Claude Huriez
Lille

France
CHU Montpellier - Hôpital Saint Eloi
Montpellier

France
Centre Hospitalier Lyon-Sud
Pierre-Benite

Germany
Universitatsklinikum Koeln
Koeln

Germany
LMU Klinikum der Universitat Muenchen
Munich

Germany
Universitaetsklinikum Ulm
Ulm

Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo

Italy
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Naples

Japan
National Cancer Center Hospital
Chuo-ku

Japan
Kyushu University Hospital
Fukuoka

Japan
Toranomon Hospital
Minato-ku

Japan
Hokkaido University Hospital
Sapporo-shi, Hokkaido

Spain
Universitario de Salamanca - Hospital Clinico
Salamanca

Spain
Hospital Universitario Virgen del Rocio
Sevilla

Sweden
Karolinska University Hospital
Stockholm

United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital
London

United Kingdom
The Christie NHS Foundation Trust
Withington

Sponsors and Collaborators

Celgene

Investigators

Study Director: Thalia Farazi, M.D./Ph.D Celgene Medical Director

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