Idecabtagene vicleucel
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-IDECABTAGENE-VICLEUCEL |
|---|---|
| Type | Drug |
| Aliases | Abecmabb2121ide-celІдекабтаген віклейцел |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | DIS-MM |
| Sources | SRC-ESMO-MM-2023 SRC-KARMMA-MUNSHI-2021 SRC-NCCN-MM-2025 |
Drug Facts
| Class | BCMA-directed autologous CAR-T cell therapy (4-1BB costimulation; murine scFv binder) |
|---|---|
| Mechanism | Autologous T cells transduced with a lentiviral vector encoding a chimeric antigen receptor (CAR) containing a murine anti-BCMA single-chain variable fragment (scFv), a CD8α hinge/ transmembrane region, a 4-1BB costimulatory domain, and a CD3- zeta activation domain. Recognizes B-cell maturation antigen (BCMA), expressed on malignant plasma cells. After lymphodepleting fludarabine + cyclophosphamide conditioning, a single IV infusion produces in vivo CAR-T expansion, peak ~7-11 days post-infusion, with sustained cytotoxicity against BCMA+ myeloma cells. First CAR-T therapy approved for multiple myeloma (FDA Mar 2021, KarMMa). Expanded to 2L+ R/R MM (KarMMa-3) in 2024 for triple-class-exposed patients. |
| Typical dosing | Single IV infusion, target dose 300-460 × 10⁶ CAR-positive viable T cells (range 150-510 × 10⁶; flat dosing, not weight-based). Administered 2-7 days after lymphodepleting conditioning: cyclophosphamide 300 mg/m² IV daily × 3 days + fludarabine 30 mg/m² IV daily × 3 days (days -5 to -3). Tocilizumab on-site (≥2 doses) before infusion is mandatory per REMS. No maintenance; single infusion. Bridging therapy may be used during the 4-6 week manufacturing window. Re-treatment not currently approved. Dose hold / delay if active infection, ANC <1,000/µL prior to lymphodepletion, or rapidly progressive extramedullary disease (consider re-bridging). |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-29 |
Warnings
- Cytokine release syndrome (CRS) — Grade ≥3 ~5% in KarMMa (any-grade ~85%); tocilizumab + ICU support mandatory
- Immune effector cell-associated neurotoxicity syndrome (ICANS) — Grade ≥3 ~3%
- Hemophagocytic lymphohistiocytosis / macrophage activation syndrome (HLH/MAS)
- Prolonged and recurrent cytopenias with secondary infections
- Secondary T-cell malignancies (FDA class boxed warning, 2024)
- REMS / FACT-JACIE accreditation required for administration
Notes
Pivotal: KarMMa (Munshi et al., NEJM 2021) — 128 heavily pretreated R/R MM patients (median 6 prior lines), ORR 73%, CR 33%, median PFS ~8.8 months. FDA approval Mar 2021; KarMMa-3 (NEJM 2023) shifted approval to 2L+ in triple-class- exposed patients. Compared to cilta-cel: shorter response duration but earlier-line approval and broader manufacturing capacity (BMS/2seventy partnership). Manufacturing window 4-6 weeks. Ukraine: NOT registered, NO domestic CAR-T manufacturing. Access only via cross-border referral (EBMT/JACIE EU centers) under "Лікування за кордоном" (наказ МОЗ 988); approximate all-in cost USD 420-520K including manufacturing, lymphodepletion, ICU support, and post-CAR-T immunoglobulin replacement / infection prophylaxis. Compare to teclistamab/elranatamab (BCMA × CD3 bispecifics) — off-the-shelf alternatives with no manufacturing delay but lower depth/duration of response than CAR-T in KarMMa-3 head-to-head against standard regimens.
Used By
Regimens
REG-IDECEL-MM-3L- Idecabtagene vicleucel (ide-cel) BCMA CAR-T for triple-class-exposed R/R multiple myeloma...