Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT04162756
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:
NCT04162756
Study Brief:
Protocol Section:
NCT04162756