NCT04162756

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

A Multicenter, Open-label, Expanded Access Study of KTE-X19 for the Treatment of Subjects With Relapsed/Refractory B-Cell Malignancies

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Relapse/Refractory Mantle Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Brexucabtagene Autoleucel (KTE-X19)	A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
DRUG	Fludarabine	Administered per package insert
DRUG	Cyclophosphamide	Administered per package insert

Timeline

• First posted: 2019-11-14
• Last updated: 2021-10-14

Locations

9 sites across 1 country: United States