Table 1.
Summary of Subject Characteristics Pre-Infusion
| Characteristic | SCRI-CAR19v2 N (%) or median (Q1, Q3) N=21 |
SCRI-CAR19v1 N (%) or median (Q1, Q3) N=43 |
P Value |
|---|---|---|---|
| Age, yrs | 13 (8, 17) | 12 (6, 17) | 0.8 |
| Female | 7 (33%) | 22 (51%) | 0.2 |
| Disease Status | 0.07 | ||
| Primary refractory | 4 (19%) | 2 (5%) | |
| 1st relapse | 5 (24%) | 16 (37%) | |
| 2nd relapse | 6 (29%) | 20 (47%) | |
| 3rd relapse | 6 (29%) | 5 (12%) | |
| ALC, cells/uL | 840 (545, 1420) | 954 (529, 1664) | 0.6 |
| History of HSCT | 0.3 | ||
| 0 | 11 (52%) | 15 (35%) | |
| 1 | 10 (43%) | 24 (56%) | |
| 2 | 4 (9%) | ||
| Time from most recent HSCT, mo* | 18.7 (8.8, 43.2) | 18.6 (10.6, 34.5) | 1.0 |
| Disease Burden | 0.02 | ||
| M1 | 10 (48%) | 8 (19%) | |
| M2 | 3 (14%) | 6 (14%) | |
| M3 | 7 (33%) | 22 (51%) | |
| Poor quality | 1 (5%) | 0 (0%) | |
| MRD-negative | 0 (0%) | 7 (16%) | |
| CD19 leukemic blasts (%) | 18 (0.05, 66) | 22.5 (0.34, 75.8) | 0.8 |
| CD19 antigen load (%) | 30.2 (5.8, 76.1) | 37.8 (12,79.1) | 0.8 |
| CNS Status | 0.4 | ||
| CNS1 | 18 | 40 | |
| CNS2 | 3 | 3 | |
| CNS3 | 0 | 0 |
CNS, central nervous system – status is pre-lymphodepletion
ALC, absolute lymphocyte count; taken at apheresis
HSCT – hematopoietic stem cell transplant,
*
calculated using only subjects who received prior HSCT
P value is calculated using Wilcoxon rank sum tests for continuous variables, Fischer exact tests for categorical variables, and log rank test for time to event variables