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A Phase 1-2 Multi-Center Study Evaluating KTE-C19 in Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (ZUMA-1) (ZUMA-1)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Kite Pharma, Inc.
Sponsor:
Information provided by (Responsible Party):
Kite Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT02348216
First received: January 22, 2015
Last updated: May 1, 2017
Last verified: May 2017
  Purpose
This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in refractory aggressive Non-Hodgkin Lymphoma (NHL).

Condition Intervention Phase
Refractory Diffuse Large B Cell Lymphoma Refractory Primary Mediastinal B Cell Lymphoma Refractory Transformed Follicular Lymphoma Relapsed/Refractory Transplant Ineligible Diffuse Large B Cell Lymphoma Relapsed/Refractory Transplant Ineligible Primary Mediastinal B Cell Lymphoma Relapsed/Refractory Transplant Ineligible Transformed Follicular Lymphoma Biological: KTE-C19 Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1-2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (NHL)

Resource links provided by NLM:


Further study details as provided by Kite Pharma, Inc.:

Primary Outcome Measures:
  • Phase 1: Safety (Incidence of adverse events defined as dose-limiting toxicities (DLT) [ Time Frame: 30 Days ]
    Incidence of adverse events defined as dose-limiting toxicities (DLT)

  • 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:
  • Duration of Response [ Time Frame: 12 Months ]
  • Progression Free Survival [ Time Frame: 12 Months ]
  • Overall Survival [ Time Frame: 12 Months ]
  • Safety [ Time Frame: 12 Months ]
    Incidence of adverse events and clinically significant changes in safety lab values, including subgroup analyses


Estimated Enrollment: 142
Study Start Date: January 2015
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

Key Inclusion Criteria

  1. Histologically confirmed:

    • Diffuse Large B Cell Lymphoma (DLBCL)
    • Primary Mediastinal Large B Cell Lymphoma (PMBCL)
    • Transformation Follicular Lymphoma (TFL)
  2. Chemotherapy-refractory disease, defined as one of more of the following:

    • No response to last line of therapy i. PD as best response to most recent therapy regimen ii. SD as best response to most recent therapy with duration no longer than 6 month from last dose of therapy OR
    • Refractory post-ASCT i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed subjects) ii. If salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy
  3. Subjects must have received adequate prior therapy including at a minimum:

    • anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative and
    • an anthracycline containing chemotherapy regimen
    • for subjects with transformed FL must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL
  4. At least one measurable lesion per revised IWG Response Criteria
  5. Age 18 or older
  6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  7. ANC ≥ 1000/uL
  8. ALC >100/uL
  9. Platelet count ≥ 75,000/uL
  10. Adequate renal, hepatic, pulmonary and cardiac function defined as:

    • Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min
    • Serum ALT/AST <2.5 ULN
    • Total bilirubin <1.5 mg/dl, except in subjects with Gilbert's syndrome
    • Cardiac ejection fraction >50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant pleural effusion
    • Baseline oxygen saturation >92% on room air
  11. All subjects or legally appointed representatives/caregivers, must personally sign and date the IRB/IEC approved consent form before initiating any study specific procedures or activities.

Key Exclusion Criteria

  1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
  2. History of allogeneic stem cell transplantation
  3. Prior CAR therapy or other genetically modified T cell therapy
  4. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment
  5. Known history of infection with HIV or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing
  6. Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases
  7. History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02348216

Contacts
Contact: Allison Bowen, MPM, PMP, BS, BA (404) 7927824 allison.bowen@theoremclinical.com

  Show 26 Study Locations
Sponsors and Collaborators
Kite Pharma, Inc.
Investigators
Study Director: William Go, M.D., Ph.D. Kite Pharma, Inc.
  More Information

Responsible Party: Kite Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02348216     History of Changes
Other Study ID Numbers: KTE-C19-101
Study First Received: January 22, 2015
Last Updated: May 1, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017