Clinical Trial: NCT02601313
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Kite, A Gilead Company |
| Information Provided By: | Gilead Sciences |
| Last Update Posted: | 2026-03-18 |
Study Overview
Brief 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).
Official Title
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma
Conditions
Relapsed/Refractory Mantle Cell Lymphoma
Intervention / Treatment
- Biological: brexucabtagene autoleucel
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Axicabtagene Ciloleucel
Other Study ID Numbers
- KTE-C19-102
- 2015-005008-27
- 2023-506641-35
- 2023
- 2015
Start Date (Actual)
2015-11-09
Primary Completion Date (Actual)
2023-09-22
Study Completion Date (Actual)
2023-09-22
Enrollment (Actual)
105
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Kite, A Gilead Company |
| Information Provided By: | Gilead Sciences |
| Last Update Posted: | 2026-03-18 |
Study Overview
Brief 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).
Official Title
A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma
Conditions
Relapsed/Refractory Mantle Cell Lymphoma
Intervention / Treatment
- Biological: brexucabtagene autoleucel
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Axicabtagene Ciloleucel
Other Study ID Numbers
- KTE-C19-102
- 2015-005008-27
- 2023-506641-35
- 2023
- 2015
Start Date (Actual)
2015-11-09
Primary Completion Date (Actual)
2023-09-22
Study Completion Date (Actual)
2023-09-22
Enrollment (Actual)
105
Study Type
Interventional
Phase
Phase 2