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Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies (ZUMA-18)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04162756
Expanded Access Status : Approved for marketing
First Posted : November 14, 2019
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Tracking Information
First Submitted Date November 11, 2019
First Posted Date November 14, 2019
Last Update Posted Date October 14, 2021
 
Descriptive Information
Brief Title Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies
Brief Summary

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)
Detailed Description

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
Intervention
  • Biological: Brexucabtagene Autoleucel (KTE-X19)
    A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
    Other Name: Tecartus™
  • Drug: Fludarabine
    Administered per package insert
  • Drug: Cyclophosphamide
    Administered per package insert
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
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  
 
Administrative Information
NCT Number NCT04162756
Current Responsible Party Gilead Sciences ( Kite, A Gilead Company )
Original Responsible Party Same as current
Current Study Sponsor Kite, A Gilead Company
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Kite Study Director Kite, A Gilead Company
PRS Account Gilead Sciences
Verification Date October 2021