# Idecabtagene vicleucel

Source: https://onco.cc/drugs/idecabtagene-vicleucel/  
OnCo record `idecabtagene-vicleucel` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Idecabtagene vicleucel was the first myeloma CAR-T (2021) and is now approved after two prior lines based on KarMMa-3.

## Summary

Idecabtagene vicleucel is an autologous CAR-T in which a lentiviral vector adds a murine scFv anti-BCMA receptor with 4-1BB costimulation to the patient's T cells, infused once after lymphodepletion. It was the first myeloma CAR-T, approved in 2021 after at least 4 lines on KarMMa (ORR 73%, CR 33%). KarMMa-3 showed PFS 13.3 versus 4.4 months (HR 0.49) against standard regimens in triple-class-exposed patients, leading to approval after at least 2 lines in April 2024; OS was not significantly different unadjusted, and whether crossover-adjusted analyses favouring ide-cel should count remains debated. Cytokine release syndrome occurred in 88% (5% grade 3 or higher) and neurotoxicity in 15%; the REMS was removed in 2025. BMS and 2seventy bio developed it. It is a one-time infusion of engineered immune cells that tripled the time without progression in heavily pretreated myeloma.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Abecma
- Code: ide-cel
- Modality: CAR-T (BCMA)
- Mechanism: Murine scFv anti-BCMA CAR with 4-1BB costimulation; lentiviral.
- Approvals: US 2021: Relapsed/refractory myeloma after ≥4 lines; US 2024: After ≥2 lines including IMiD, PI, and anti-CD38
- Dosing: IV single infusion; 300-510 × 10⁶ CAR+ T cells after fludarabine/cyclophosphamide lymphodepletion
- Toxicity (grade 3+): Cytokine release syndrome 5%; Neurotoxicity 3%; Neutropenia 76%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Idecabtagene_vicleucel
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Idecabtagene%20vicleucel

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Relapsed or refractory multiple myeloma](https://onco.cc/cancers/myeloma-relapsed-refractory/)
- technologies: [Autologous CAR-T manufacturing, batch by batch](https://onco.cc/technologies/car-t-manufacturing-process/), [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- targets: [BCMA](https://onco.cc/targets/bcma/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- terms: [Crossover in trials](https://onco.cc/terms/crossover/), [Cytokine release syndrome (CRS)](https://onco.cc/terms/crs/), [ICANS (neurotoxicity)](https://onco.cc/terms/icans/)
- trials: [A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alo](https://onco.cc/trials/nct06045806/), [KarMMa-3](https://onco.cc/trials/karmma-3/)
- key papers: [KarMMa-3: ide-cel CAR-T versus standard regimens in triple-class-exposed relapsed myeloma](https://onco.cc/key-papers/paper-karmma-3-ide-cel-nejm-2023/)
- biomarkers: [BCMA expression](https://onco.cc/biomarkers/bcma-expression/)

---
JSON: https://onco.cc/api/v1/entities/idecabtagene-vicleucel.json