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Study to Evaluate the Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) (ZUMA-2)

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ClinicalTrials.gov Identifier: NCT04880434
Recruitment Status : Recruiting
First Posted : May 10, 2021
Last Update Posted : October 12, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Brief Summary:
The primary objective is to evaluate the efficacy of brexucabtagene autoleucel (KTE-X19) in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL) in Cohort 3 of this study.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Mantle Cell Lymphoma Drug: Fludarabine Drug: Cyclophosphamide Biological: Brexucabtagene autoleucel Phase 2

Detailed Description:

Study KTE-C19-102 (NCT02601313) enrolled participants with r/r MCL who have been treated with up to 5 prior regimens including a Bruton's tyrosine kinase inhibitor (BTKi) in Cohort 1 and Cohort 2. However, to fulfill FDA Postmarketing Requirement Cohort 3 is added to the study. It will include participants with r/r MCL who have been treated with up to 5 prior regimens but have not received prior therapy with a BTKi.

The primary analysis in Cohort 1 and Cohort 2 is already completed. Data for Cohort 3 will be analyzed separately. Therefore, this separate registration is only for Cohort 3.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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
Actual Study Start Date : April 27, 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2038

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Brexucabtagene autoleucel (KTE-X19)
Participants with relapsed/refractory mantle cell lymphoma will receive conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day intravenous (IV) infusion for 3 days followed by a single infusion of brexucabtagene autoleucel (KTE-X19) at a targeted dose of 2 x 10^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg, with a maximum flat dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0 in Cohort 3.
Drug: Fludarabine
Administered intravenously

Drug: Cyclophosphamide
Administered intravenously

Biological: Brexucabtagene autoleucel
A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells
Other Names:
  • KTE-X19
  • TECARTUS™




Primary Outcome Measures :
  1. Objective Response Rate (ORR) Per Lugano Classification as Determined by the Independent Radiology Review Committee (IRRC) [ Time Frame: Up to 2 years ]
    ORR is defined as the incidence of either a complete response (CR) or partial response (PR) per the Lugano Classification as determined by IRRC.


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Up to 7 years ]
    DOR is defined as the time from their first objective response to disease progression or death.

  2. Percentage of Participants With Best Objective Response (BOR) [ Time Frame: Up to 7 years ]
    Best objective response is defined as the incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable as best response to treatment.

  3. Objective Response Rate (ORR) per Lugano Classification as Determined by Investigators [ Time Frame: Up to 7 years ]
    ORR, as determined by investigators, is defined as the incidence of either a complete response (CR) or partial response (PR) per the Lugano Classification.

  4. Progression Free Survival (PFS) [ Time Frame: Up to 7 years ]
  5. Overall Survival [ Time Frame: Up to 7 years ]
  6. Percentage of Participants Experiencing Treatment-Emergent Adverse Events [ Time Frame: Up to 7 years ]
  7. Percentage of Participants With Clinically Significant Changes in Laboratory Values [ Time Frame: Up to 7 years ]
  8. Percentage of Participants Who Develop Anti-CD19 CAR Antibodies [ Time Frame: Up to 7 years ]
  9. Levels of Anti-CD19 CAR T Cells in Blood [ Time Frame: Up to 7 years ]
  10. Levels of Cytokines in Serum [ Time Frame: Up to 7 years ]
  11. Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Scale Score [ Time Frame: Baseline and up to 24 months ]
    The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline.

  12. Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Visual Analogue Scale (VAS) Score [ Time Frame: Baseline and up to 24 months ]
    EQ-5D is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ5D-VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicates better self-reported health status.

  13. Changes in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score from Baseline Over Time [ Time Frame: Baseline and up to 6 months ]
    EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions use 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores are averaged, transformed to 0-100 scale; higher score indicate high QoL. A positive change from baseline indicates better quality of life.



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

Key Inclusion Criteria:

  • Up to 5 prior regimens for MCL. Prior therapy must have included anthracycline- or bendamustine-containing chemotherapy and anti-CD20 monoclonal antibody therapy. Individuals must not have received prior therapy with a BTKi.
  • At least 1 measurable lesion
  • Platelet count ≥ 75,000/uL
  • Creatinine clearance (as estimated by Cockcroft Gault) ≥ to 60 cc/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 human immunodeficiency virus (HIV) or hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive). Individuals with a history of hepatitis infection must have cleared their infection as determined by 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 ClinicalTrials.gov identifier (NCT number): NCT04880434


Contacts
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Contact: Medical Information 844-454-5483(1-844-454-KITE) medinfo@kitepharma.com

Locations
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Sponsors and Collaborators
Kite, A Gilead Company
Investigators
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Study Director: Kite Study Director Kite, A Gilead Company
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Responsible Party: Kite, A Gilead Company
ClinicalTrials.gov Identifier: NCT04880434    
Other Study ID Numbers: KTE-C19-102 (Cohort 3)
2015-005008-27 ( EudraCT Number )
First Posted: May 10, 2021    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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