Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies (ZUMA-18)
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|ClinicalTrials.gov Identifier: NCT04162756|
Expanded Access Status : Approved for marketing
First Posted : November 14, 2019
Last Update Posted : October 14, 2021
|First Submitted Date||November 11, 2019|
|First Posted Date||November 14, 2019|
|Last Update Posted Date||October 14, 2021|
|Brief Title||Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies|
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)
This is an open-label, expanded access study of KTE-X19 for the treatment of individuals with r/r B-cell malignancies. The study will consist of 2 cohorts as indicated below:
Cohort 1 will enroll individuals prior to commercial availability of KTE-X19 for the proposed indication.
Cohort 2 will enroll individuals after KTE-X19 becomes commercially available in cases when KTE-X19 does not meet commercial release specification(s).
The participants who received an infusion of KTE-X19 will be provided the opportunity to transition to a separate long-term follow-up (LTFU) study, KT-US-982-5968.
|Study Type||Expanded Access|
|Expanded Access Type||Treatment IND/Protocol|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Approved for marketing|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Responsible Party||Gilead Sciences ( Kite, A Gilead Company )|
|Study Sponsor||Kite, A Gilead Company|
|PRS Account||Gilead Sciences|
|Verification Date||October 2021|