At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 105 enrolled
Drug / intervention
brexucabtagene autoleucel +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating brexucabtagene autoleucel, Cyclophosphamide, and 2 other interventions for Relapsed/Refractory Mantle Cell Lymphoma. Completed, enrolled 105 participants across 32 sites in 4 countries.
Detailed Summary
The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed/Refractory Mantle Cell Lymphoma
CountriesFrance, Germany, Netherlands, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartNov 2015
First PostedNov 2015
Primary CompletionSep 2023
TodayJul 2026
First PostedNov 10, 2015
Enrollment StartNov 9, 2015
Primary CompletionSep 22, 2023
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 10.6 years ago
Interventions
brexucabtagene autoleucelbiological
A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells
Cyclophosphamidedrug
Administered intravenously
Fludarabinedrug
Administered intravenously
Axicabtagene Ciloleuceldrug
A single infusion of axicabtagene ciloleucel anti-CD 19 CAR T cells