Table 2.

AEs related to HBI0101 therapy

Event and gradeTotal (N = 50)
CRS 
Any grade, n (%) 48 (96%) 
17 (34%) 
24 (48%) 
7 (14%) 
CRS start day, median (range) 0 (0-4) 
CRS duration days, median (range) 1 (1-7) 
Tocilizumab use, n (%) 40 (80%) 
Tocilizumab doses, median (range) 1 (0-4) 
Steroids use, n (%) 8 (16%) 
Vasopressors, n (%) 7 (14%) 
Neurotoxicity 
Any, n (%) 3 (6%) 
Neurologic deterioration (delirium), n (%) 1 (2%) 
ICANS (grade 1-2), n (%) 2 (4%) 
ICANS start day, median (range) 2 (2-2) 
ICANS duration, median (range), d 2.5 (2-3) 
Hematologic toxicity ≤28 d 
Neutropenia, n (%)  
Any grade 49 (98%) 
Grade 3-4 49 (98%) 
Thrombocytopenia, n (%)  
Any grade 36 (72%) 
Grade 3-4 27 (54%) 
Anemia, n (%)  
Any grade 44 (88%) 
Grade 3-4 31 (62%) 
Lymphopenia, n (%)  
Any grade 50 (100%) 
Grade 3-4 50 (100%) 
Febrile neutropenia, n (%)  
Any grade 36 (72%) 
Grade 3-4 36 (72%) 
Supportive care  
G-CSF, n (%) 32 (64%) 
Blood transfusion, n (%) 14 (28%) 
Platelet transfusion, n (%) 10 (20%) 
Nonhematologic toxicity ≤28 d, n (%) 
Renal failure  
Any grade 9 (18%) 
Grade 1 8 (16%) 
Grade 2 1 (2%) 
E/LFT  
Any grade 10 (20%) 
Grade 1 7 (14%) 
Grade 2 2 (4%) 
Grade 3 1 (2%) 
HLH-like 4 (8%) 
Bacteremia 4 (8%) 
Other infections 5 (10%) 
Hospitalization stay median (d) 24 (14-55) 
Event and gradeTotal (N = 50)
CRS 
Any grade, n (%) 48 (96%) 
17 (34%) 
24 (48%) 
7 (14%) 
CRS start day, median (range) 0 (0-4) 
CRS duration days, median (range) 1 (1-7) 
Tocilizumab use, n (%) 40 (80%) 
Tocilizumab doses, median (range) 1 (0-4) 
Steroids use, n (%) 8 (16%) 
Vasopressors, n (%) 7 (14%) 
Neurotoxicity 
Any, n (%) 3 (6%) 
Neurologic deterioration (delirium), n (%) 1 (2%) 
ICANS (grade 1-2), n (%) 2 (4%) 
ICANS start day, median (range) 2 (2-2) 
ICANS duration, median (range), d 2.5 (2-3) 
Hematologic toxicity ≤28 d 
Neutropenia, n (%)  
Any grade 49 (98%) 
Grade 3-4 49 (98%) 
Thrombocytopenia, n (%)  
Any grade 36 (72%) 
Grade 3-4 27 (54%) 
Anemia, n (%)  
Any grade 44 (88%) 
Grade 3-4 31 (62%) 
Lymphopenia, n (%)  
Any grade 50 (100%) 
Grade 3-4 50 (100%) 
Febrile neutropenia, n (%)  
Any grade 36 (72%) 
Grade 3-4 36 (72%) 
Supportive care  
G-CSF, n (%) 32 (64%) 
Blood transfusion, n (%) 14 (28%) 
Platelet transfusion, n (%) 10 (20%) 
Nonhematologic toxicity ≤28 d, n (%) 
Renal failure  
Any grade 9 (18%) 
Grade 1 8 (16%) 
Grade 2 1 (2%) 
E/LFT  
Any grade 10 (20%) 
Grade 1 7 (14%) 
Grade 2 2 (4%) 
Grade 3 1 (2%) 
HLH-like 4 (8%) 
Bacteremia 4 (8%) 
Other infections 5 (10%) 
Hospitalization stay median (d) 24 (14-55) 

CMV, cytomegalovirus; E/LFT, electrolytes or liver function tests; G-CSF, granulocyte colony-stimulating factor; HLH-like, hemophagocytic lymphohistiocytosis-like syndrome; RSV, respiratory syncytial virus.

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