Demographics of patients with B-ALL
Characteristics . | Subjects 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%) | 0 | |
>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%) | 0 | 2 (33.3%)‡ | |
Marrow disease burden at initiation of LD | ||||
MRD negativeǁ | 1 (5%) | 1 (7.1%) | 0 | |
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%) |
Characteristics . | Subjects 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%) | 0 | |
>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%) | 0 | 2 (33.3%)‡ | |
Marrow disease burden at initiation of LD | ||||
MRD negativeǁ | 1 (5%) | 1 (7.1%) | 0 | |
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.
One subject with ALL did not have bone marrow involvement, however, had extramedullary disease.