CARTITUDE-1
Ciltacabtagene autoleucel in relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study
Phase 1/2N = 113NCT03548207
- Population
- Myeloma after three or more previous lines, or double-refractory to a proteasome inhibitor and an immunomodulatory drug, with previous proteasome inhibitor, immunomodulatory drug and anti-CD38 antibody; median of six previous therapies.
- Design
- Single-arm, open-label phase 1b/2 study at 16 US centres. A single infusion of cilta-cel at 0.75 x 10^6 CAR-positive viable T cells per kg followed lymphodepletion. Primary end points were safety and recommended phase 2 dose (phase 1b) and overall response rate (phase 2); 113 patients were enrolled and 97 were treated at the recommended dose.
- Primary endpoint
- ORR
- Arms
- Ciltacabtagene autoleucel (experimental, n = 97): Cilta-cel 0.75 x 10^6 CAR+ viable T cells per kg, single infusion
- People
- Berdeja JG
Show the numbers
| Endpoint | Analysis | Ciltacabtagene autoleucel | Control | Effect |
|---|---|---|---|---|
| ORRTreated patients (97) | primarymedian follow-up 12.4 monthsBerdeja 2021 | 97% (91.2–99.4%) | — | Cytokine release syndrome occurred in 95% (4% grade 3 or 4); CAR T-cell neurotoxicity in 21% (9% grade 3 or 4). 14 deaths occurred in the study: six due to treatment-related adverse events, five to progressive disease and three to treatment-unrelated adverse events. |
| sCR rateTreated patients (97) | primaryBerdeja 2021 | 67% | — | — |
| PFSTreated patients (97) | primaryBerdeja 2021 | 77% at 12 mo (66.0–84.3%) | — | Median progression-free survival and median duration of response were not reached. |
| OSTreated patients (97) | primaryBerdeja 2021 | 89% at 12 mo (80.2–93.5%) | — | — |
| Endpoint | Analysis | Ciltacabtagene autoleucel | Control | Effect |
|---|---|---|---|---|
| ORRTreated patients (97) | primarymedian follow-up 12.4 monthsBerdeja 2021 | 97% (91.2–99.4%) | — | Cytokine release syndrome occurred in 95% (4% grade 3 or 4); CAR T-cell neurotoxicity in 21% (9% grade 3 or 4). 14 deaths occurred in the study: six due to treatment-related adverse events, five to progressive disease and three to treatment-unrelated adverse events. |
| sCR rateTreated patients (97) | primaryBerdeja 2021 | 67% | — | — |
| PFSTreated patients (97) | primaryBerdeja 2021 | 77% at 12 mo (66.0–84.3%) | — | Median progression-free survival and median duration of response were not reached. |
| OSTreated patients (97) | primaryBerdeja 2021 | 89% at 12 mo (80.2–93.5%) | — | — |
Appears in
Sources
Berdeja JG, Madduri D, Usmani SZ, Jakubowiak A, Agha M, Cohen AD, et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021;398(10297):314-324.