Selected AEs∗
| AE . | Grade 1, number of patients (%) . | Grade 2, number of patients (%) . | Grade 3, number of patients (%) . | Grade 4, number of patients (%) . |
|---|---|---|---|---|
| CRS | ||||
| Any CRS | 4 (19) | 6 (29) | 1 (4.8)† | − |
| Tocilizumab for CRS | 1 (4.8) | 1 (4.8) | − | − |
| Corticosteroids for CRS | − | − | − | − |
| Neurologic toxicity | ||||
| Neurologic toxicity‡ | NR | 5 (24) | − | − |
| Dizziness | NR | 2 (9.5) | − | − |
| Confusion | NR | 1 (4.8) | − | − |
| Headache | NR | 1 (4.8) | − | − |
| Hallucinations | NR | 1 (4.8) | − | − |
| Corticosteroids for neurologic toxicity | NR | − | − | − |
| Rash | ||||
| Rash, maculopapular, pustular, or eczematous | NR | 6 (29) | 3 (14) | − |
| Systemic corticosteroids for rash | NR | − | 2 (9.5) | − |
| Hematologic | ||||
| Neutropenia | NR | 2 (9.5) | 7 (33) | 12 (57) |
| Thrombocytopenia | NR | 4 (19) | 1 (4.8) | 4 (19) |
| Anemia | NR | 4 (19) | 6 (29) | − |
| TTHR and interventions for hematologic toxicity | ||||
| TTHR ≥ 30 days§ | 5 (24) | |||
| TTHR ≥ 90 days§ | 2 (9.5) | |||
| Delayed grade 3/4 cytopenias after day +30|| | 4 (21) | |||
| Eltrombopag for cytopenias | 3 (14) | |||
| Corticosteroids for cytopenias | 2 (9.5) | |||
| AE . | Grade 1, number of patients (%) . | Grade 2, number of patients (%) . | Grade 3, number of patients (%) . | Grade 4, number of patients (%) . |
|---|---|---|---|---|
| CRS | ||||
| Any CRS | 4 (19) | 6 (29) | 1 (4.8)† | − |
| Tocilizumab for CRS | 1 (4.8) | 1 (4.8) | − | − |
| Corticosteroids for CRS | − | − | − | − |
| Neurologic toxicity | ||||
| Neurologic toxicity‡ | NR | 5 (24) | − | − |
| Dizziness | NR | 2 (9.5) | − | − |
| Confusion | NR | 1 (4.8) | − | − |
| Headache | NR | 1 (4.8) | − | − |
| Hallucinations | NR | 1 (4.8) | − | − |
| Corticosteroids for neurologic toxicity | NR | − | − | − |
| Rash | ||||
| Rash, maculopapular, pustular, or eczematous | NR | 6 (29) | 3 (14) | − |
| Systemic corticosteroids for rash | NR | − | 2 (9.5) | − |
| Hematologic | ||||
| Neutropenia | NR | 2 (9.5) | 7 (33) | 12 (57) |
| Thrombocytopenia | NR | 4 (19) | 1 (4.8) | 4 (19) |
| Anemia | NR | 4 (19) | 6 (29) | − |
| TTHR and interventions for hematologic toxicity | ||||
| TTHR ≥ 30 days§ | 5 (24) | |||
| TTHR ≥ 90 days§ | 2 (9.5) | |||
| Delayed grade 3/4 cytopenias after day +30|| | 4 (21) | |||
| Eltrombopag for cytopenias | 3 (14) | |||
| Corticosteroids for cytopenias | 2 (9.5) | |||
NR, not recorded, as grade 1 AEs were not recorded on this trial, except for CRS grading; (−) no AEs of the indicated category and grade occurred on the trial.
The highest grade alone recorded for each patient. AEs were recorded according to the Common Terminology Criteria for Adverse Events version 5.0. CRS was graded according to Lee et al.29 No grade 5 events occurred on trial.
One patient had grade 3 CRS due to hypotension lasting 34 hours requiring intermittent low-dose vasopressor support. This patient did not receive tocilizumab because of the transient nature of the vasopressor support required, per institutional guidelines at the time of CAR T-cell infusion.
Attributed to CAR T cells.
TTHR defined as number of days until grade 3 or 4 anemia, thrombocytopenia, and neutropenia are resolved with no transfusion support or growth factors for at least 7 days, starting from the date of cell infusion.
Delayed grade 3 or 4 cytopenias occurring after hematologic recovery was previously achieved and after day +30. Two patients with TTHR of >30 days achieved hematologic recovery and later developed delayed cytopenias. Two patients were not evaluable because of cytopenias beginning within 30 days of CAR T-cell infusion and lasting >90 days (patients 15 and 18 of cohort 1).