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

  • STATUS
    Recruiting
  • End date
    Dec 11, 2038
  • participants needed
    90
  • sponsor
    Kite, A Gilead Company
Updated on 11 November 2021

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.

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.

Details
Condition Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma
Treatment cyclophosphamide, Fludarabine, Brexucabtagene autoleucel
Clinical Study IdentifierNCT04880434
SponsorKite, A Gilead Company
Last Modified on11 November 2021

Eligibility

Yes No Not Sure

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

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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