Table 2.
Any time AEs (n = 20) |
Short-term AEs (n = 20) |
Long-term AEs (n = 12) |
|
---|---|---|---|
CRS | |||
Any grade | 20 (100%) | 20 (100%) | 0 |
Grade 3–4 | 2 (10%) | 2 (10%) | 0 |
Grade 5 | 0 | 0 | 0 |
Neurological events | |||
Any grade | 3 (15%) | 3 (15%) | 0 |
Grade 3–4 | 0 | 0 | 0 |
Grade 5 | 0 | 0 | 0 |
GVHD | |||
Any grade | 16 (80%) | 12 (60%) | 7 (58%) |
Grade 3–4 | 1 (5%) | 0 | 1 (8%) |
Grade 5 | 0 | 0 | 0 |
Infection | |||
Any grade | 6 (30%) | 3 (15%) | 6 (50%) |
Grade 3–4 | 1 (5%) | 0 | 1 (8%) |
Grade 5 | 4 (20%) | 0 | 4 (33%) |
Data presented as No, (%) unless otherwise specified
Any time AEs indicate AEs that occurred at any time post-CAR T-cell infusion in all 20 treated patients; short-term AEs indicate AEs that occurred within 30 days post-CAR T-cell infusion in all 20 treated patients; long-term AEs indicated AEs that occurred after 30 days post-CAR T-cell infusion in 12 patients who received prior-SCT donor-derived CAR T cells but did not further undergo a SCT consolidation. Among the 8 patients who received new donor derived CD7 CAR T cells, one was off-study at day 15, and seven proceeded to SCT at about day 30, therefore discontinued monitoring for AEs after 30 days. Cytopenias were described in the text of this report. Other short-term AEs had been previously reported. No other grade 3 or worse AEs occurred in the long-term follow-up
AEs—adverse events; CRS—cytokine release syndrome; GVHD—graft-versus-host disease