Patient characteristics
| Characteristic . | CAR-naïve (n = 68) . | CAR-exposed (n = 13) . |
|---|---|---|
| CAR product | ||
| Investigational CTL019 | 44 (64.7) | |
| Investigational huCART19 | 13 (19.1) | 13 (100.0) |
| Commercial tisagenlecleucel | 11 (16.2) | |
| Median age at initial diagnosis (range), y | 6.0 (0.24-19.5) | 3.7 (1.3-15.0) |
| Median age at CARTi (range), y | 11.3 (1.7-24.5) | 9.7 (5.9-20.0) |
| Median age at CARTr (range), y | 11.9 (2.0-25.1) | 9.9 (6.2-20.4) |
| Female sex | 28 (41.2) | 3 (23.1) |
| Race | ||
| White | 53 (77.9) | 9 (69.2) |
| Black or African-American | 4 (5.9) | 0 (0.0) |
| Asian | 0 (0.0) | 1 (7.7) |
| Other | 11 (16.2) | 2 (15.4) |
| Unknown | 0 (0.0) | 1 (7.7) |
| Ethnicity | ||
| Non-Hispanic | 60 (88.2) | 10 (76.9) |
| Hispanic | 8 (11.8) | 3 (23.1) |
| Trisomy 21 | 2 (2.9) | 1 (7.7) |
| Prior HSCT | 30 (44.1) | 8 (61.5) |
| Prior blinatumomab | 6 (8.8) | 0 (0.0) |
| Prior inotuzumab | 3 (4.4) | 3 (23.1) |
| Disease status at CARTi | ||
| Primary refractory | 13 (19.1) | 1 (7.7) |
| First relapse | 17 (25.0) | 2 (15.4) |
| Second relapse | 29 (42.7) | 5 (38.5) |
| Third or greater relapse | 9 (13.2) | 5 (38.5) |
| BM blasts, pre-CARTi | ||
| MRD− | 28 (41.2) | 7 (53.9) |
| MRD+, < 5% | 18 (26.5) | 2 (15.4) |
| 5%-24.99% | 5 (7.4) | 1 (7.7) |
| ≥25% | 17 (25.0) | 3 (23.1) |
| CRS maximum grade after CARTi | ||
| None or mild (grade 1/2) CRS | 58 (85.3) | 11 (84.6) |
| Moderate (grade 3) CRS | 5 (7.4) | 2 (15.4) |
| Severe (grade 4) CRS | 5 (7.4) | 0 (0.0) |
| Characteristic . | CAR-naïve (n = 68) . | CAR-exposed (n = 13) . |
|---|---|---|
| CAR product | ||
| Investigational CTL019 | 44 (64.7) | |
| Investigational huCART19 | 13 (19.1) | 13 (100.0) |
| Commercial tisagenlecleucel | 11 (16.2) | |
| Median age at initial diagnosis (range), y | 6.0 (0.24-19.5) | 3.7 (1.3-15.0) |
| Median age at CARTi (range), y | 11.3 (1.7-24.5) | 9.7 (5.9-20.0) |
| Median age at CARTr (range), y | 11.9 (2.0-25.1) | 9.9 (6.2-20.4) |
| Female sex | 28 (41.2) | 3 (23.1) |
| Race | ||
| White | 53 (77.9) | 9 (69.2) |
| Black or African-American | 4 (5.9) | 0 (0.0) |
| Asian | 0 (0.0) | 1 (7.7) |
| Other | 11 (16.2) | 2 (15.4) |
| Unknown | 0 (0.0) | 1 (7.7) |
| Ethnicity | ||
| Non-Hispanic | 60 (88.2) | 10 (76.9) |
| Hispanic | 8 (11.8) | 3 (23.1) |
| Trisomy 21 | 2 (2.9) | 1 (7.7) |
| Prior HSCT | 30 (44.1) | 8 (61.5) |
| Prior blinatumomab | 6 (8.8) | 0 (0.0) |
| Prior inotuzumab | 3 (4.4) | 3 (23.1) |
| Disease status at CARTi | ||
| Primary refractory | 13 (19.1) | 1 (7.7) |
| First relapse | 17 (25.0) | 2 (15.4) |
| Second relapse | 29 (42.7) | 5 (38.5) |
| Third or greater relapse | 9 (13.2) | 5 (38.5) |
| BM blasts, pre-CARTi | ||
| MRD− | 28 (41.2) | 7 (53.9) |
| MRD+, < 5% | 18 (26.5) | 2 (15.4) |
| 5%-24.99% | 5 (7.4) | 1 (7.7) |
| ≥25% | 17 (25.0) | 3 (23.1) |
| CRS maximum grade after CARTi | ||
| None or mild (grade 1/2) CRS | 58 (85.3) | 11 (84.6) |
| Moderate (grade 3) CRS | 5 (7.4) | 2 (15.4) |
| Severe (grade 4) CRS | 5 (7.4) | 0 (0.0) |
Data are displayed as median (IQR) unless otherwise indicated.
BM, bone marrow; CNS, central nervous system; Cy, cyclophosphamide; Flu, fludarabine; LD, lymphodepleting.
Data are displayed as n (%) unless otherwise indicated.
BM, bone marrow.