for people ages 18 years and up (full criteria)
study started
estimated completion



The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).

Official Title

A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma


Study KTE-C19-102 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, details for Cohort 3 were registered separately (NCT04880434) on as this cohort will not be part of the main study analysis.

After the end of KTE-C19-102, subjects who received an infusion of anti-CD19 CAR T cells will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968


Relapsed/Refractory Mantle Cell Lymphoma, Lymphoma, Mantle-Cell Lymphoma, Cyclophosphamide, Fludarabine, brexucabtagene autoleucel, Axicabtagene Ciloleucel, Axicabtagene ciloleucel/brexucabtagene autoleucel (KTE-X19)


You can join if…

Open to people ages 18 years and up

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 or acalabrutinib At least 1 measurable lesion Platelet count ≥ 75,000/uL Creatinine clearance (as estimated by Cockcroft Gault) > or = to 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.

You CAN'T join if...

  • Known history of infection with human immunodeficiency virus (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.


  • University California Los Angeles (UCLA)
    Santa Monica California 90404 United States
  • City of Hope
    Duarte California 91010 United States
  • Stanford University
    Stanford California 94305 United States


in progress, not accepting new patients
Start Date
Completion Date
Kite, A Gilead Company
Gilead Clinical Trials Website
Phase 2 research study
Study Type
About 105 people participating
Last Updated