Table 1.

Demographics of patients with B-ALL

CharacteristicsSubjects treated (n = 20)CAR naïve (n = 14)CAR pretreated (n = 6)
Age, median (y), range 20.5 (5.4-34.6) 25.2 (5.4-34.6) 19.1 (8.3-23.8) 
Sex    
 Male 12 (60%) 9 (64.3%) 3 (50%) 
 Female 8 (40%) 5 (35.7%) 3 (50%) 
Disease status and prior therapy    
 2-3 previous lines of therapy 8 (40%) 8 (57.1%) 
 >4 previous lines of therapy 12 (60%) 6 (42.9%) 6 (100%) 
No. of prior allogeneic transplants    
 0 (HSCT naïve) 8 (40%) 7 (50%) 1 (16.7%) 
 ≥1 12 (60%) 7 (50%) 5 (83.3%) 
Prior immunotherapy    
 Prior CD19 targeted therapy* 15 (75%) 9 (64.3%) 6 (100%) 
 Type of CD19 targeted therapy    
  Prior blinatumomab 14 (70%) 8 (57.1%) 6 (100%) 
  Prior CD19 CAR T cells 7 (35%) 2 (14.3%) 5 (83.3%) 
 Prior CD22 targeted therapy§ 6 (30%) 1 (7.1%) 5 (83.3%) 
 Type of CD22 targeted therapy    
  Prior inotuzumab 5 (25%) 1 (7.1%) 4 (66.7%) 
  Prior CD22 CAR T cells 2 (10%) 2 (33.3%) 
Marrow disease burden at initiation of LD    
 MRD negativeǁ 1 (5%) 1 (7.1%) 
 M1 10 (50%) 7 (50%) 3 (50%) 
 ≥M2 9 (45%) 6 (42.9%) 3 (50%) 
CNS disease status at initiation of LD    
 CNS1 17 (85%) 12 (85,7%) 5 (83.3%) 
 CNS1 with flow + disease 3 (15%) 2 (14.3%) 1 (16.7%) 
Extramedullary disease status at initiation of LD    
 Extramedullary disease (Non-CNS) at treatment 8 (40%) 6 (42.8%) 2 (33.3%) 
CharacteristicsSubjects treated (n = 20)CAR naïve (n = 14)CAR pretreated (n = 6)
Age, median (y), range 20.5 (5.4-34.6) 25.2 (5.4-34.6) 19.1 (8.3-23.8) 
Sex    
 Male 12 (60%) 9 (64.3%) 3 (50%) 
 Female 8 (40%) 5 (35.7%) 3 (50%) 
Disease status and prior therapy    
 2-3 previous lines of therapy 8 (40%) 8 (57.1%) 
 >4 previous lines of therapy 12 (60%) 6 (42.9%) 6 (100%) 
No. of prior allogeneic transplants    
 0 (HSCT naïve) 8 (40%) 7 (50%) 1 (16.7%) 
 ≥1 12 (60%) 7 (50%) 5 (83.3%) 
Prior immunotherapy    
 Prior CD19 targeted therapy* 15 (75%) 9 (64.3%) 6 (100%) 
 Type of CD19 targeted therapy    
  Prior blinatumomab 14 (70%) 8 (57.1%) 6 (100%) 
  Prior CD19 CAR T cells 7 (35%) 2 (14.3%) 5 (83.3%) 
 Prior CD22 targeted therapy§ 6 (30%) 1 (7.1%) 5 (83.3%) 
 Type of CD22 targeted therapy    
  Prior inotuzumab 5 (25%) 1 (7.1%) 4 (66.7%) 
  Prior CD22 CAR T cells 2 (10%) 2 (33.3%) 
Marrow disease burden at initiation of LD    
 MRD negativeǁ 1 (5%) 1 (7.1%) 
 M1 10 (50%) 7 (50%) 3 (50%) 
 ≥M2 9 (45%) 6 (42.9%) 3 (50%) 
CNS disease status at initiation of LD    
 CNS1 17 (85%) 12 (85,7%) 5 (83.3%) 
 CNS1 with flow + disease 3 (15%) 2 (14.3%) 1 (16.7%) 
Extramedullary disease status at initiation of LD    
 Extramedullary disease (Non-CNS) at treatment 8 (40%) 6 (42.8%) 2 (33.3%) 

Data presented as n (%) unless otherwise indicated. Definitions: M1: <5% blasts in the bone marrow; M2: 5%-25% blasts in bone marrow; M3: >25% blasts in bone marrow. CNS1: No blasts on cytospin; CNS1 + flow cytometry positive: No blasts on cytospin however blasts detected by multiparametric flow cytometry.

*

Five subjects received both CD19 CAR and blinatumomab.

Two subjects received prior CD19 CAR and had an interval HSCT thus are considered CAR naïve.

One patient received prior CAR treatment with both a CD19 and a CD19/CD22 CAR T-cell infusion before receipt of this CAR construct.

§

One subject received prior CD22 CAR and inotuzumab.

ǁ

One subject with ALL did not have bone marrow involvement, however, had extramedullary disease.