Ciltacabtagene autoleucel (cilta-cel) BCMA CAR-T for R/R multiple myeloma after ≥3 prior lines — single infusion after Flu/Cy lymphodepletion (CARTITUDE-1)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | None declared |
|---|
| ID | REG-CILTACEL-MM-3L |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-CARTITUDE-1-BERDEJA-2021 SRC-NCCN-MM-2025 |
Notes
CARTITUDE-1 (NCT03548207, Berdeja Lancet 2021): single-infusion cilta-cel (BCMA-directed CAR-T, 4-1BB costimulation, tandem 2-epitope llama-derived scFv) in heavily pretreated R/R multiple myeloma after ≥3 prior lines including PI + IMiD + anti-CD38 (n=97, median 6 prior lines). ORR 97%, sCR 67%; 27-mo PFS 55%, 27-mo OS 70% (Martin JCO 2023 follow-up). Best-in-class BCMA CAR-T efficacy but cilta-cel-specific MNT (~5% movement / parkinsonism) requires risk mitigation (low tumor burden at infusion; aggressive CRS/ICANS treatment). FDA approval Feb 2022 (3L+, this regimen). Subsequent CARTITUDE-4 expanded to 2L (separate Regimen REG-CILTACEL-MM-2L). Centre must be FACT/JACIE/REMS-accredited. Boxed warnings: CRS, ICANS, MNT (delayed neurotoxicity), HLH/MAS, prolonged cytopenia, secondary T-cell malignancy. Single curative-intent attempt; no maintenance. STUB — pending Co-Lead sign-off.
Used By
Indication
IND-MM-RR-3L-CILTACEL- IND-MM-RR-3L-CILTACEL
Regimen
REG-CILTACEL-LYMPHODEPLETION-FLU-CY- Lymphodepleting fludarabine + cyclophosphamide conditioning before ciltacabtagene autoleu...