Table 1.
Patient, disease, and enterocolitis characteristics.
| Demographic characteristics at infusion | n (%) |
|---|---|
| Male gender | 7 (50) |
| Age in years, median (range) | 64 (39–79) |
| ECOG performance status, median (range) | 1 (0–1) |
| History of inflammatory bowel disease | 1 (7) |
| Disease and treatment characteristics | |
| Extramedullary disease at infusion | 2 (14) |
| Prior lines of therapy, median (range) | 4.5 (4–7) |
| Prior stem cell transplantation | 12 (86) |
| CAR-T product type | |
| Cilta-cel | 13 (93) |
| Ide-cel | 1 (7) |
| Biomarkers at infusion, median (range) | |
| Absolute lymphocyte count (x109/L) (n = 14) | 0.47 (0.0–3.46) |
| C-reactive protein (mg/L) (n = 13) | 2.9 (0.3–60.9) |
| Ferritin (ng/mL) (n = 13) | 120 (37–1819) |
| Biomarker maximum values, median (range) | |
| C-reactive protein (mg/L) (n = 13) | 19.4 (1.8–194.8) |
| Ferritin (ng/mL) (n = 13) | 420 (111–11214) |
| Any-grade CRS | 13 (93) |
| CRS grade ≥2 | 4 (29) |
| Any-grade ICANS | 1 (7) |
| ICANS grade ≥2 | 1 (7) |
| ≥PR to CAR-T | 10 (71) |
| AE characteristics at symptom onset | |
| Days after infusion, median (range) | 92.5 (22–210) |
| Days after CRS resolution, median (range) | 85 (2–205) |
| Highest CTCAE grade, median (range) | 3 (1–5) |
| Diagnostic presentation | |
| Non-bloody diarrhea | 13 (87) |
| Radiographic enteritis or colitisa (n = 14) | 6 (43) |
| Biomarkers at onset, median (range) | |
| Absolute lymphocyte count (x109/L) (n = 13) | 0.84 (0.12–3.02) |
| C-reactive protein (mg/L) (n = 9) | 3.30 (0.3–14.7) |
| Ferritin (ng/mL) (n = 6) | 92 (33–3462) |
| IgG mg/dL (n = 14) | 326.5 (25–778) |
| AE treatment and outcomes | |
| Systemic corticosteroid use | 10 (71) |
| Intravenous corticosteroids | 4 (40) |
| Oral corticosteroids | 6 (60) |
| Duration of corticosteroids in days, median (range) | 31 (1–45) |
| Infliximab use | 6 (43) |
| Infliximab doses, median (range)b | 1 (1–3) |
| Clinical benefit from infliximab (n = 6) | 3 (50) |
| Vedolizumab use | 3 (20) |
| Vedolizumab doses, median (range)b | 2 (2-2) |
| Clinical benefit from vedolizumab (n = 3) | 1 (33) |
| AE status (as of data cutoff) | |
| Resolution of symptoms | 4 (28) |
| Ongoing symptoms | 5 (36) |
| Death due to enterocolitis | 5 (36) |
| Days to symptom resolution, median (range)a | 113 (76–188) |
AE adverse event, CAR-T chimeric antigen receptor T-cell therapy, CRS cytokine release syndrome, CTCAE Common Terminology Criteria for Adverse Events, dl deciliter, ECOG Eastern Cooperative Oncology Group, ICANS immune effector cell-associated neurotoxicity syndrome, L liter, mg milligrams, mL milliliter, ng nanograms, PR partial response, IgG immunoglobulin G.
aOnly in patients with resolved symptoms.
bWhen administered, infliximab and vedolizumab were dosed with an interval of 2 weeks between the second dose and the first dose and an interval of 6 weeks between the third dose and the second dose.