Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies

APPROVED_FOR_MARKETING

Conditions studied: Relapse/Refractory Mantle Cell Lymphoma

In brief

The primary objectives of this study are: Cohort 1: to provide access to brexucabtagene autoleucel (KTE-X19) for individuals with relapsed or refractory (r/r) mantle cell lymphoma (MCL) until KTE-X19 is commercially available Cohort 2: To provide access to KTE-X19 for individuals with r/r MCL whose commercially manufactured product did not meet commercial release specification(s)

Key facts

Study ID

NCT04162756

Run by

Kite, A Gilead Company

Last updated by the study team

2021-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Stanford Cancer Institute — Stanford, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Sarah Cannon Research Institute — Nashville, Tennessee, United States
• Henry-Joyce Cancer Clinic — Nashville, Tennessee, United States
• The University of TX MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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