Brexucabtagene autoleucel
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-BREXUCABTAGENE-AUTOLEUCEL |
|---|---|
| Type | Drug |
| Aliases | TecartusБрексукабтаген аутолейцел |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-MCL |
| Sources | SRC-NCCN-BCELL-2025 |
Drug Facts
| Class | Anti-CD19 CD28-costimulated CAR-T cell therapy (autologous; T-cell selection by CD4/CD8 + CD19 depletion process step) |
|---|---|
| Mechanism | Autologous T-cells engineered with anti-CD19 CAR (CD28 costim + CD3-zeta activation, identical receptor construct to axi-cel) but manufactured with a CD19-depletion step prior to transduction — reduces malignant CD19+ B-cell contamination of the apheresis product (clinically meaningful in leukemic MCL where circulating malignant cells are prominent). Following lymphodepleting conditioning, engineered cells expand in vivo, recognize CD19+ B-cells, trigger cytotoxic killing. |
| Typical dosing | Target 2 × 10^6 anti-CD19 CAR+ T-cells/kg (max 2 × 10^8) — single IV infusion after fludarabine 30 mg/m² + cyclophosphamide 500 mg/m² IV days -5 to -3 lymphodepletion |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-27 |
Warnings
- Cytokine release syndrome (CRS) — can be fatal
- Immune effector cell-associated neurotoxicity syndrome (ICANS) — can be fatal
- Hemophagocytic lymphohistiocytosis (HLH/MAS)
- Prolonged cytopenia + B-cell aplasia / hypogammaglobulinemia
- Secondary malignancies (T-cell lymphoma, FDA boxed 2024)
Notes
ZUMA-2 (Wang 2020): r/r MCL after prior cBTKi (median 3 prior lines) — ORR 91%, CR 68%, 3-yr OS ~60%. First and only CAR-T approved for MCL. Higher Grade ≥3 ICANS in MCL setting (~31%) vs DLBCL (~28%) — MCL patients tend to be older + heavily pretreated. CD19-depletion manufacturing step distinguishes brexu-cel from axi-cel — needed due to leukemic-phase MCL contamination of apheresis. Centre must be FACT/JACIE/REMS-accredited. Tocilizumab on-site mandatory. Major UA access barrier: not registered.
Used By
Regimens
REG-CAR-T-BREXUCEL-MCL- Brexucabtagene autoleucel (brexu-cel) CAR-T for r/r MCL — single infusion after lymphodep...