COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 1 of 2 for:    KTE-X19 MCL
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02601313
Recruitment Status : Active, not recruiting
First Posted : November 10, 2015
Last Update Posted : April 24, 2020
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

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

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Mantle Cell Lymphoma Biological: KTE-X19 Drug: Cyclophosphamide Drug: Fludarabine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)
Actual Study Start Date : November 2015
Actual Primary Completion Date : July 24, 2019
Estimated Study Completion Date : May 2034

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: KTE-X19
Experimental: Single Arm. A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion CAR transduced autologous T cells administered intravenously.
Biological: KTE-X19
Drug: Cyclophosphamide
Administered intravenously

Drug: Fludarabine
Administered intravenously

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Up to 24 months ]
    Objective response rate (ORR) is defined as the incidence of a CR or a PR per the Lugano Classification (Cheson et al, 2014), as determined by the Independent Radiology Review Committee (IRRC).

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: Up to 24 months ]
    Duration of response (DOR) is defined as the time from their first objective response to disease progression or death.

  2. Best Objective Response [ Time Frame: Up to 24 months ]
    Best objective response is defined as the incidence of CR, PR, SD, progressive disease, or unevaluable as best response to treatment

  3. Progression Free Survival [ Time Frame: Up to 24 months ]
    Progression free survival (PFS) is defined as the time from the anti‑CD19 CAR T cells infusion date to the date of disease progression or death from any cause

  4. Objective Response Rate [ Time Frame: Up to 24 months ]
    Objective response rate (ORR) is defined as the incidence of either a CR or PR determined by investigator

  5. Overall Survival [ Time Frame: Up to 15 years ]
    Percentage of participants experiencing treatment-emergent adverse events; Percentage of participants who had clinically significant changes in laboratory values.

  6. Incidence of adverse events (AEs) and clinically significant changes in laboratory values [ Time Frame: Up to 15 years ]
    Percentage of Participants Experiencing Treatment-Emergent Adverse Events; Percentage of participants who had clinically significant changes in laboratory values.

  7. Incidence of anti-CD19 CAR antibodies [ Time Frame: Up to 15 years ]
  8. Levels of anti-CD19 CAR T cells in blood [ Time Frame: Up to 15 years ]
  9. Levels of cytokines in serum [ Time Frame: Up to 15 years ]
  10. Changes over time in the EQ-5D scale score and visual analogue scale score [ Time Frame: Up to 6 months ]
    The EQ-5D consists of a 5-dimension descriptive system, including questions on mobility, self-care, usual activities, pain/comfort, and anxiety/depression, and a visual analogue scale (VAS) that allows the respondent to record health on a vertical scale (eg, best health to worst health), thus allowing a quantitative measure of health outcome.

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.

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

Key Inclusion Criteria:

Up to 5 prior regimens for mantle cell lymphoma (MCL). Prior therapy must have included:

  • Anthracycline or bendamustine-containing chemotherapy and
  • Anti-CD20 monoclonal antibody therapy and
  • Ibrutinib or acalabrutinib

At least 1 measurable lesion

Platelet count ≥ 75,000/uL

Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min

Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings

Baseline oxygen saturation >92% on room air.

Key Exclusion Criteria:

  • 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 standard serological and genetic testing
  • History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with central nervous system (CNS) involvement
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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 identifier (NCT number): NCT02601313

Show Show 32 study locations
Sponsors and Collaborators
Kite, A Gilead Company
Layout table for investigator information
Study Director: Kite Study Director Kite, A Gilead Company
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kite, A Gilead Company Identifier: NCT02601313    
Other Study ID Numbers: KTE-C19-102
2015-005008-27 ( EudraCT Number )
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists