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A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)

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ClinicalTrials.gov Identifier: NCT02601313
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : October 5, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of KTE-C19 in subjects with Relapsed/Refractory MCL

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Mantle Cell Lymphoma Biological: KTE-C19 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL) (ZUMA-2)
Study Start Date : November 2015
Estimated Primary Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: KTE-C19
Experimental: Single Arm A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously at a target dose of 2 x 10^6 anti-CD19 CAR+ T cells/kg
Biological: KTE-C19

Outcome Measures

Primary Outcome Measures :
  1. Phase 2: Overall Response Rate [ Time Frame: 12 months ]
    • Objective response rate (complete response [CR] + partial response [PR]) per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: 12 Months ]
  2. Best Objective Response [ Time Frame: 12 Months ]
  3. Progression Free Survival [ Time Frame: 12 Months ]

Eligibility Criteria

Information from the National Library of Medicine

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

Key Inclusion Criteria:

  • Pathologically confirmed MCL
  • Up to 5 prior regimens for MCL. Prior therapy must have included:

    • Anthracycline or bendamustine-containing chemotherapy and
    • Anti-CD20 monoclonal antibody therapy and
    • Ibrutinib
  • Relapsed or refractory disease, defined by the following:

    • Disease progression after last regimen, or
    • Refractory disease is defined failure to achieve a PR or CR to the last regimen
  • At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma
  • Age 18 years or older
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  • ANC ≥ 1000/µL
  • Platelet count ≥ 50,000/µL
  • Adequate renal, hepatic, and cardiac function defined as:

    • Serum creatinine ≤ 1.5 mg/dL
    • Serum ALT/AST ≤ 2.5 ULN
    • Total bilirubin ≤ 1.5 mg/dL, except in subjects with Gilbert's syndrome.
    • Cardiac ejection fraction ≥ 50% (by ECHO) and no evidence of pericardial effusion as determined by an ECHO.

Key Exclusion Criteria:

  • History of malignancy other than nonmelanomatous skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
  • History of allogeneic stem cell transplantation
  • Prior CD19 targeted therapy
  • Prior CAR therapy or other genetically modified T cell therapy
  • Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive)
  • Subjects with detectable cerebrospinal fluid malignant cells or brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases
  • History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601313

Contact: Medical Information 844-454-KITE medinfo@kitepharma.com

United States, Arizona
Banner MD Anderson Recruiting
Gilbert, Arizona, United States, 85234
Contact: Andrea Winkle       andrea.winkle@bannerhealth.com   
Principal Investigator: Javier Munoz, MD, FACP         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Hormoz Mirshkarlo       hmirshkarlo@coh.org   
UC San Diego Moores Cancer Center Withdrawn
La Jolla, California, United States, 92093
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Juliana Craig       jkcraig@stanford.edu   
Principal Investigator: David Miklos, MD, PhD         
United States, Colorado
Sarah Cannon Recruiting
Denver, Colorado, United States, 80218
Contact: Juli Murphy       juli.murphy@healthonecares.com   
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Nathalie Luis       nluis@med.miami.edu   
Principal Investigator: Amer Beitinjaneh         
H Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Matthew Scott       matthew.scott@moffitt.org   
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Neera Jagirdar       neera.jagirdar@emory.edu   
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Ray Robinson       rrobinson7@medicine.bsd.uchicago.edu   
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Michael Rocchio       MichaelJ_Rocchio@DFCI.HARVARD.EDU   
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Marie Ventimiglia       ventimim@karmanos.org   
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Kelly Azzollini       Kelly.Azzollini@hackensackmeridian.org   
United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Frances Batarse       frances_batarse@urmc.rochester.edu   
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Donna Abounader       abounad2@ccf.org   
United States, Oregon
Robert W. Franz Cancer Research Center Recruiting
Portland, Oregon, United States, 97213
Contact: Laurie Delanty       laurie.delanty@providence.org   
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Christy Riggins       Christy.Riggins@scresearch.net   
United States, Texas
Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Sandy Li       Sandy.Li@BSWHealth.org   
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Maria Badillo       mrbadill@mdanderson.org   
Contact: Onyeka Oriabure       ONOkonkwo@mdanderson.org   
Principal Investigator: Michael (Luhua) Wang, MD         
Methodist Hospital Recruiting
San Antonio, Texas, United States, 78229
Contact: JoDell McCracken       jodell.mccracken@mhshealth.com   
United States, Washington
Swedish Cancer Institute Recruiting
Seattle, Washington, United States, 98104
Contact: Melinh Jones-Nozynski    206-215-2338    melinh.jones@swedish.org   
Sponsors and Collaborators
Kite, A Gilead Company
Study Director: William Go, M.D., Ph.D. Kite, A Gilead Company
More Information

Responsible Party: Kite, A Gilead Company
ClinicalTrials.gov Identifier: NCT02601313     History of Changes
Other Study ID Numbers: KTE-C19-102
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin