CD22 CAR T-cell subject characteristics and clinical outcomes stratified by carHLG toxicity
| . | No car HLG . | Car HLG . | P . |
|---|---|---|---|
| Patients with toxicity (among those with CRS*), overall, n (%) | 31/52 (59.6%) | 21/52 (40.4%) | NS |
| Subject characteristics | 17 (4-30) | 13 (4-30) | NS |
| Age (y) median (range) | 12/31 (38.7) | 6/21 (28.6) | NS |
| Female, n (%) | 23/31 (74.2) | 13/21 (61.9) | NS |
| Prior treatments | |||
| Patients with prior HSCT, n (%) | 23/31 (74.2) | 13/21 (61.9) | NS |
| Patients with prior blinatumomab, n (%) | 15/31 (48.3) | 11/21 (52.4) | NS |
| Patients with prior inotuzumab, n (%) | 6/31 (19.4) | 7/21 (33.3) | NS |
| Patients with prior CAR, n (%) | 20/31 (64.5) | 11/21 (52.4) | NS |
| Disease burden | |||
| Pre-CAR baseline disease burden, median (IQR) | 50 (18.9-90) | 71.4 (40.8-88.5) | NS |
| Extramedullary disease, n (%) | 5.31 (16.1) | 5/21 (28.3) | NS |
| Toxicity outcomes | |||
| Time to CRS onset, days postinfusion, median (range) | 8 (3-13) | 7.5 (3-13) | NS |
| CRS duration, d, median (range) | 6 (4-12) | 5.5 (2-13) | NS |
| Time to carHLG onset, d, median (range) | — | 14 (7-26) | — |
| Time from CRS onset to carHLG onset, d, median (range) | — | 6 (2-17) | — |
| Max grade CRS* | |||
| Grade 1/2 (%)* | 25/31 (80.6) | 15/21 (71.4) | — |
| Grade 3/4 (%) | 6/31 (19.3) | 6/21 (28.6) | — |
| Tocilizumab utilization (%) | 7/31 (25.8) | 17/21 (81.0) | <.0001 |
| Clinical outcomes† | |||
| Objective response (MRD/CR, CR, PR), n (%) | 24/30 (80.0) | 19.21 (90.5) | NS |
| . | No car HLG . | Car HLG . | P . |
|---|---|---|---|
| Patients with toxicity (among those with CRS*), overall, n (%) | 31/52 (59.6%) | 21/52 (40.4%) | NS |
| Subject characteristics | 17 (4-30) | 13 (4-30) | NS |
| Age (y) median (range) | 12/31 (38.7) | 6/21 (28.6) | NS |
| Female, n (%) | 23/31 (74.2) | 13/21 (61.9) | NS |
| Prior treatments | |||
| Patients with prior HSCT, n (%) | 23/31 (74.2) | 13/21 (61.9) | NS |
| Patients with prior blinatumomab, n (%) | 15/31 (48.3) | 11/21 (52.4) | NS |
| Patients with prior inotuzumab, n (%) | 6/31 (19.4) | 7/21 (33.3) | NS |
| Patients with prior CAR, n (%) | 20/31 (64.5) | 11/21 (52.4) | NS |
| Disease burden | |||
| Pre-CAR baseline disease burden, median (IQR) | 50 (18.9-90) | 71.4 (40.8-88.5) | NS |
| Extramedullary disease, n (%) | 5.31 (16.1) | 5/21 (28.3) | NS |
| Toxicity outcomes | |||
| Time to CRS onset, days postinfusion, median (range) | 8 (3-13) | 7.5 (3-13) | NS |
| CRS duration, d, median (range) | 6 (4-12) | 5.5 (2-13) | NS |
| Time to carHLG onset, d, median (range) | — | 14 (7-26) | — |
| Time from CRS onset to carHLG onset, d, median (range) | — | 6 (2-17) | — |
| Max grade CRS* | |||
| Grade 1/2 (%)* | 25/31 (80.6) | 15/21 (71.4) | — |
| Grade 3/4 (%) | 6/31 (19.3) | 6/21 (28.6) | — |
| Tocilizumab utilization (%) | 7/31 (25.8) | 17/21 (81.0) | <.0001 |
| Clinical outcomes† | |||
| Objective response (MRD/CR, CR, PR), n (%) | 24/30 (80.0) | 19.21 (90.5) | NS |
BM, bone marrow; CR, complete remission; IQR, interquartile range; MRD, minimal residual disease; NS, not significant; PB, peripheral blood; PR, partial response. P values determined using Fisher’s exact and Mann-Whitney U tests for categorical and continuous variables, respectively, except max grade CRS, which used a χ-square test.
CRS (cytokine release syndrome) was defined by ASTCT criteria.
One patient was not evaluable (subject 24) due to grade 5 capillary leak syndrome on day +9 postinfusion prior to disease restaging.