Factors related to occurrence and severity of CRS/NEs
| . | CRS . | NEs . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade . | Analysis . | Grade . | Analysis . | ||||||||||
| Univariate . | Multivariate* . | Univariate . | Multivariate* . | ||||||||||
| 0-2 . | 3-4 . | 5 . | P . | OR . | 95% CI . | P . | 0-2 . | 3-4 . | P . | OR . | 95% CI . | P . | |
| Median age (range), y | 32 (8-68) | 26 (6-66) | 22 | .543 | 27 (8-68) | 23 (6-61) | .635 | ||||||
| Disease status | .843 | .705 | |||||||||||
| BM + CNS | 29 (80.6) | 6 (16.7) | 1 (2.8) | 27 (75.0) | 9 (25.0) | ||||||||
| Isolated CNS | 10 (83.3) | 2 (16.7) | 0 | 10 (83.3) | 2 (16.7) | ||||||||
| Infused cells | .145 | 1.000 | |||||||||||
| Isolated CD19 | 30 (81.1) | 7 (18.9) | 0 | 28 (75.7) | 9 (24.3) | ||||||||
| Combined CD19 + CD22 | 9 (81.8) | 1 (9.1) | 1 (9.1) | 9 (81.8) | 2 (18.2) | ||||||||
| Costimulator | .425 | .611 | |||||||||||
| 4-1BB | 26 (81.3) | 6 (18.8) | 0 | 25 (78.1) | 7 (21.9) | ||||||||
| CD28 | 4 (80) | 1 (20) | 0 | 3 (60) | 2 (40) | ||||||||
| CD28 + 4-1BB | 9 (81.8) | 1 (9.1) | 1 (9.1) | 9 (81.8) | 2 (18.2) | ||||||||
| Average dose, ×106/kg | .373 | .615 | |||||||||||
| <3 | 19 (73.1) | 7 (26.9) | 0 | 20 (76.9) | 6 (23.1) | ||||||||
| 3-5 | 12 (92.3) | 1 (7.7) | 0 | 11 (84.6) | 2 (15.4) | ||||||||
| >5 | 8 (88.9) | 0 | 1 (11.1) | 6 (66.7) | 3 (33.3) | ||||||||
| CNS-directed bridging treatment | .465 | 1.000 | |||||||||||
| Yes | 23 (85.2) | 4 (14.8) | 0 | 21 (77.8) | 6 (22.2) | ||||||||
| No | 16 (76.2) | 4 (19.0) | 1 (4.8) | 16 (76.2) | 5 (23.8) | ||||||||
| CNS status before infusion | .798 | .083 | 1.530 | 1.260-5.171 | .034† | ||||||||
| 1 | 3 (100) | 0 | 0 | 3 (100) | 0 | ||||||||
| 2 | 13 (86.7) | 2 (13.3) | 0 | 14 (93.3) | 1 (6.7) | ||||||||
| 3 | 23 (76.7) | 6 (20.0) | 1 (3.3) | 20 (66.7) | 10 (33.3) | ||||||||
| BM blasts before infusion, % | .636 | .514 | |||||||||||
| <5 | 18 (81.8) | 4 (18.2) | 0 | 18 (81.8) | 4 (18.2) | ||||||||
| ≥5 | 21 (80.8) | 4 (15.4) | 1 (3.8) | 19 (73.1) | 7 (26.9) | ||||||||
| Median peak CAR DNA copies in PB (range), per μg | 50 118 (2 733-108 747) | 296 728 (10 699-5 888 436) | 981 213 | <.001† | 4.230 | 1.043-10.425 | .002† | 66 069 (2 733-630 957) | 398 107 (63 095-5 888 436) | <.001† | 2.017 | 0.972-4.216 | .014† |
| Median peak sIL-6 (range), pg/mL | 107 (29-375) | 349 (135 to >2 000) | >2 000 | .012† | 2.355 | 1.430-5.026 | .035† | 209 (29-491) | 1 589 (135 to >2 000) | .037† | 3.103 | 2.987-6.260 | .001† |
| Median blasts in CSF (range), % | 10.9 (6.4-35.6) | 14.6 (3.8-50.2) | 15.6 | .270 | 10.6 (3.8-26.8) | 26.3 (10.6-50.2) | .038† | 1.642 | 1.051-3.730 | .037† | |||
| . | CRS . | NEs . | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Grade . | Analysis . | Grade . | Analysis . | ||||||||||
| Univariate . | Multivariate* . | Univariate . | Multivariate* . | ||||||||||
| 0-2 . | 3-4 . | 5 . | P . | OR . | 95% CI . | P . | 0-2 . | 3-4 . | P . | OR . | 95% CI . | P . | |
| Median age (range), y | 32 (8-68) | 26 (6-66) | 22 | .543 | 27 (8-68) | 23 (6-61) | .635 | ||||||
| Disease status | .843 | .705 | |||||||||||
| BM + CNS | 29 (80.6) | 6 (16.7) | 1 (2.8) | 27 (75.0) | 9 (25.0) | ||||||||
| Isolated CNS | 10 (83.3) | 2 (16.7) | 0 | 10 (83.3) | 2 (16.7) | ||||||||
| Infused cells | .145 | 1.000 | |||||||||||
| Isolated CD19 | 30 (81.1) | 7 (18.9) | 0 | 28 (75.7) | 9 (24.3) | ||||||||
| Combined CD19 + CD22 | 9 (81.8) | 1 (9.1) | 1 (9.1) | 9 (81.8) | 2 (18.2) | ||||||||
| Costimulator | .425 | .611 | |||||||||||
| 4-1BB | 26 (81.3) | 6 (18.8) | 0 | 25 (78.1) | 7 (21.9) | ||||||||
| CD28 | 4 (80) | 1 (20) | 0 | 3 (60) | 2 (40) | ||||||||
| CD28 + 4-1BB | 9 (81.8) | 1 (9.1) | 1 (9.1) | 9 (81.8) | 2 (18.2) | ||||||||
| Average dose, ×106/kg | .373 | .615 | |||||||||||
| <3 | 19 (73.1) | 7 (26.9) | 0 | 20 (76.9) | 6 (23.1) | ||||||||
| 3-5 | 12 (92.3) | 1 (7.7) | 0 | 11 (84.6) | 2 (15.4) | ||||||||
| >5 | 8 (88.9) | 0 | 1 (11.1) | 6 (66.7) | 3 (33.3) | ||||||||
| CNS-directed bridging treatment | .465 | 1.000 | |||||||||||
| Yes | 23 (85.2) | 4 (14.8) | 0 | 21 (77.8) | 6 (22.2) | ||||||||
| No | 16 (76.2) | 4 (19.0) | 1 (4.8) | 16 (76.2) | 5 (23.8) | ||||||||
| CNS status before infusion | .798 | .083 | 1.530 | 1.260-5.171 | .034† | ||||||||
| 1 | 3 (100) | 0 | 0 | 3 (100) | 0 | ||||||||
| 2 | 13 (86.7) | 2 (13.3) | 0 | 14 (93.3) | 1 (6.7) | ||||||||
| 3 | 23 (76.7) | 6 (20.0) | 1 (3.3) | 20 (66.7) | 10 (33.3) | ||||||||
| BM blasts before infusion, % | .636 | .514 | |||||||||||
| <5 | 18 (81.8) | 4 (18.2) | 0 | 18 (81.8) | 4 (18.2) | ||||||||
| ≥5 | 21 (80.8) | 4 (15.4) | 1 (3.8) | 19 (73.1) | 7 (26.9) | ||||||||
| Median peak CAR DNA copies in PB (range), per μg | 50 118 (2 733-108 747) | 296 728 (10 699-5 888 436) | 981 213 | <.001† | 4.230 | 1.043-10.425 | .002† | 66 069 (2 733-630 957) | 398 107 (63 095-5 888 436) | <.001† | 2.017 | 0.972-4.216 | .014† |
| Median peak sIL-6 (range), pg/mL | 107 (29-375) | 349 (135 to >2 000) | >2 000 | .012† | 2.355 | 1.430-5.026 | .035† | 209 (29-491) | 1 589 (135 to >2 000) | .037† | 3.103 | 2.987-6.260 | .001† |
| Median blasts in CSF (range), % | 10.9 (6.4-35.6) | 14.6 (3.8-50.2) | 15.6 | .270 | 10.6 (3.8-26.8) | 26.3 (10.6-50.2) | .038† | 1.642 | 1.051-3.730 | .037† | |||
Data are presented as n (%) unless otherwise specified.
OR, odds ratio.
Ordinal logistic regression was used to estimate the risk factors of the occurrence and severity of CRS/NEs. The variables that entered the multivariate regression model include variables identified by univariate analysis with P < .1.
P < .05.