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. 2021 Dec 16;138(24):2469–2484. doi: 10.1182/blood.2021011898

Table 1.

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

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.