Clinical Trials /

A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma

NCT02601313

Description:

Study KTE-C19-102 is a phase 2, multicenter, open-label study evaluating the efficacy of KTE-X19 in subjects with Relapsed/Refractory MCL

Related Conditions:
  • Mantle Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase 2 Multicenter Study Evaluating Subjects With Relapsed/Refractory Mantle Cell Lymphoma
  • 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)

Clinical Trial IDs

  • ORG STUDY ID: KTE-C19-102
  • NCT ID: NCT02601313

Conditions

  • Relapsed/Refractory Mantle Cell Lymphoma

Interventions

DrugSynonymsArms
KTE-C19KTE-C19

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
KTE-C19ExperimentalExperimental: 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

    Eligibility Criteria

            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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Phase 2: Overall Response Rate
    Time Frame:12 months
    Safety Issue:
    Description:• Objective response rate (complete response [CR] + partial response [PR]) per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma

    Secondary Outcome Measures

    Measure:Duration of Response
    Time Frame:12 Months
    Safety Issue:
    Description:
    Measure:Best Objective Response
    Time Frame:12 Months
    Safety Issue:
    Description:
    Measure:Progression Free Survival
    Time Frame:12 Months
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Kite Pharma, Inc.

    Last Updated

    July 25, 2017