Axicabtagene ciloleucel
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-AXICABTAGENE-CILOLEUCEL |
|---|---|
| Type | Drug |
| Aliases | YescartaАксікабтаген цилолейцел |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-DLBCL-NOS DIS-FL DIS-HGBL-DH |
| Sources | SRC-NCCN-BCELL-2025 |
Drug Facts
| Class | Anti-CD19 CD28-costimulated CAR-T cell therapy (autologous) |
|---|---|
| Mechanism | Autologous T-cells transduced with retroviral vector encoding a chimeric antigen receptor (CAR) targeting CD19 with CD28 costimulatory + CD3-zeta activation domains. Following lymphodepleting conditioning (fludarabine + cyclophosphamide), engineered cells expand in vivo, recognize CD19+ B-cells (malignant + normal), trigger cytotoxic killing + cytokine release. Single infusion; persistence weeks to months. |
| Typical dosing | Target dose 2 × 10^6 anti-CD19 CAR+ T-cells/kg (max 2 × 10^8) — single IV infusion, after fludarabine 30 mg/m²/day + cyclophosphamide 500 mg/m²/day × 3 days lymphodepletion (days -5 to -3) |
| 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-1 pivotal trial (r/r DLBCL after ≥2 lines): ~83% ORR, ~58% CR; durable remissions in ~40% at 5 years. ZUMA-7 moved axi-cel to 2L for primary-refractory / early-relapse DLBCL (superior EFS vs salvage + autoSCT). Tocilizumab MUST be on-site BEFORE infusion (anti-IL6R for CRS rescue). Centre must be REMS / FACT-accredited for CAR-T administration. Bridge therapy may be needed during 3-4 week manufacturing window. Major access barrier in Ukraine: not registered; international referral pathway required if patient + funding feasible.
Used By
Regimens
REG-CAR-T-AXICEL- Axicabtagene ciloleucel (axi-cel) CAR-T — single infusion after lymphodepletionREG-CAR-T-AXICEL-FL- Axicabtagene ciloleucel (axi-cel) CAR-T for r/r FL — single infusion after lymphodepletio...REG-CAR-T-AXICEL-HGBL- Axicabtagene ciloleucel (axi-cel CAR-T) for relapsed/refractory HGBL-DH