Also known as: brexu-cel
Brexucabtagene autoleucel is an autologous CD19-directed CAR-T cell gene therapy marketed as Tecartus for relapsed or refractory mantle cell lymphoma and B-cell precursor acute lymphoblastic leukemia. It is a customized cellular product made from a patient's own T cells. The therapy has U.S. and EU approvals and is prescription-only.
CAR-T toxicity management is shifting toward phenotype- and mechanism-based intervention. Key issues include CRS, ICANS, IEC-HS, and long-term risks of cytopenia and infection.
Metabolic pathway scores consistently distinguished patients who developed severe neurologic events after CAR T-cell therapy across six clinical trials, surpassing traditional inflammatory markers in predictive performance.
New antibody-based approaches demonstrate clinical benefits across multiple cancer types, including improved survival in triple-negative breast cancer, enhanced tumor detection via PET imaging, and activity in relapsed mantle cell lymphoma.
Retrospective analysis of the ZUMA-2 trial found that previous ibrutinib exposure was associated with improved progression-free survival after brexucabtagene autoleucel treatment in mantle cell lymphoma patients, though with increased toxicity.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06553872 |
Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL |
RECRUITING | PHASE2 |
| NCT05776134 |
Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel |
AVAILABLE | |
| NCT05537766 |
Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies |
TERMINATED | PHASE2 |
| NCT05041309 |
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells |
ENROLLING_BY_INVITATION | |
| NCT04880434 |
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) |
COMPLETED | PHASE2 |
| NCT03624036 |
Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
TERMINATED | PHASE1 |
| NCT02614066 |
A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3) |
COMPLETED | PHASE1/PHASE2 |
| NCT02601313 |
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) |
COMPLETED | PHASE2 |
