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

NCT04880434

CompletedPhase 2

Sponsor: Kite, A Gilead Company

Conditions: Relapsed/Refractory Mantle Cell Lymphoma

Interventions: Fludarabine, Cyclophosphamide, Brexucabtagene autoleucel

Countries: United States, France, Germany, Netherlands, Spain, United Kingdom

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) who have not previously received Bruton's tyrosine kinase inhibitor (BTKi).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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-cluster of differentiation 20 (CD20) monoclonal antibody therapy. Individuals must not have received prior therapy with a Bruton's tyrosine kinase inhibitor (BTKi).
* At least 1 measurable lesion
* Platelet count ≥ 75,000/μL
* 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) or multigated acquisition (MUGA), 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 anti-hepatitis C virus (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.
Locations (40)
  • Gilbert, Arizona, United States
  • Palo Alto, California, United States
  • Santa Monica, California, United States
  • Denver, Colorado, United States
  • Miami, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Maywood, Illinois, United States
  • Park Ridge, Illinois, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Hackensack, New Jersey, United States
  • Rochester, New York, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Seattle, Washington, United States
  • Montpellier, France
  • Paris, France
  • Pessac, France
  • Pierre-Bénite, France
  • Rennes, France
  • Mainz, Germany
  • München, Germany
  • + 10 more on CT.gov