# Ciltacabtagene autoleucel

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

## TL;DR

Ciltacabtagene autoleucel is a one-time BCMA CAR-T for myeloma that, in CARTITUDE-4, cut the risk of death by about 45% compared with standard regimens.

## Summary

Approved 2022 (≥4 lines) and 2024 (≥1 prior line, lenalidomide-refractory; CARTITUDE-4 with OS benefit HR 0.55). A third of patients in CARTITUDE-1 remain progression-free at 5 years without maintenance. Delayed neurotoxicity (parkinsonism) and secondary malignancies are rare but notable. Legend Biotech/Johnson & Johnson.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-04
- Brand: Carvykti
- Code: cilta-cel
- Modality: CAR-T (BCMA)
- Mechanism: Two BCMA-binding VHH domains, 4-1BB costimulation; lentiviral.
- Approvals: US 2022: Relapsed/refractory myeloma ≥4 lines; US 2024: Relapsed myeloma after ≥1 line, lenalidomide-refractory
- Dosing: Single IV infusion after lymphodepletion; 0.5 to 1.0 × 10⁶ CAR+ viable T cells/kg (max 1 × 10⁸); cyclophosphamide 300 mg/m² + fludarabine 30 mg/m² days −5 to −3
- Toxicity (grade 3+): Cytokine release syndrome 3%; Neutropenia (grade 3+) 95%; Hypogammaglobulinaemia 9%; Infections (grade 3+) 24%; ICANS 0.5%; Parkinsonism / movement disorders 0%

## Sources

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

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Newly diagnosed multiple myeloma, transplant-eligible](https://onco.cc/cancers/myeloma-transplant-eligible/), [Plasma cell leukaemia](https://onco.cc/cancers/plasma-cell-leukaemia/), [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: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/), [Legend Biotech](https://onco.cc/companies/legend-biotech/)
- trials: [A Study of Ciltacabtagene Autoleucel and Talquetamab for the Treatment of Participants With High-Risk Multiple Myeloma](https://onco.cc/trials/nct06550895/), [A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Ind](https://onco.cc/trials/nct06577025/), [A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Mul](https://onco.cc/trials/nct04133636/), [A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel](https://onco.cc/trials/nct07149857/), [CARTITUDE-1](https://onco.cc/trials/cartitude-1/), [CARTITUDE-4](https://onco.cc/trials/cartitude-4/), [CARTITUDE-5](https://onco.cc/trials/cartitude-5/), [CARTITUDE-6](https://onco.cc/trials/cartitude-6/), [LEGEND-2](https://onco.cc/trials/legend-2/)
- ideas: [Full refund for CAR-T if the patient has not responded at three months](https://onco.cc/ideas/idea-reg-cart-outcomes-refund/), [Mandatory public reporting of vein-to-vein time and failure rate per CAR-T product](https://onco.cc/ideas/idea-reg-vein-to-vein-public-benchmark/), [One CAR-T infusion instead of autologous transplant](https://onco.cc/ideas/idea-car-t-replaces-transplant/), [Outcome-based annuity payments for potentially curative one-time therapies](https://onco.cc/ideas/idea-fund-pay-for-cure-annuities/), [Pay-for-cure contracts: instalment payments for curative therapies contingent on durable remission](https://onco.cc/ideas/idea-moon-pay-for-cure-contracts/)
- roadmaps: [Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR](https://onco.cc/roadmaps/cell-therapy-roadmap/)
- people: [Fangliang (Frank) Zhang](https://onco.cc/people/zhang-fangliang/), [Jesús G. Berdeja](https://onco.cc/people/jesus-berdeja/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/)
- key papers: [CARTITUDE-1: cilta-cel, a BCMA CAR-T, in heavily pretreated myeloma](https://onco.cc/key-papers/paper-cartitude-1-cilta-cel-lancet-2021/), [CARTITUDE-4: cilta-cel CAR-T versus standard combinations after one to three prior lines of myeloma therapy](https://onco.cc/key-papers/paper-cartitude-4-cilta-cel-nejm-2023/)
- institutions: [Comprehensive Cancer Center Mainfranken, University Hospital Würzburg](https://onco.cc/institutions/ccc-wuerzburg/), [IUCT Oncopole (Institut Universitaire du Cancer de Toulouse)](https://onco.cc/institutions/iuct-oncopole/), [Yale University Open Data Access (YODA) Project](https://onco.cc/institutions/yoda-project/)
- biomarkers: [BCMA expression](https://onco.cc/biomarkers/bcma-expression/)

---
JSON: https://onco.cc/api/v1/entities/ciltacabtagene-autoleucel.json