Table 1.
Demographic and Clinical Characteristics of the Cohort
| Characteristic | Patients, No. (%)a | ||
|---|---|---|---|
| Total (n = 72b) |
CMV Reactivation (n = 18c) |
No CMV Reactivation (n = 54) |
|
| Follow-up, median (IQR), d | 81 (34–84) | 62 (34–84) | 81 (34–83) |
| Baseline characteristics | |||
| Age, median (IQR), y | 64 (56–70) | 62 (52–74) | 65 (57–70) |
| Female sex | 31 (43.1) | 7 (38.9) | 24 (44.4) |
| Raced | |||
| Asian | 5 (6.9) | 3 (16.7) | 2 (3.7) |
| Black | 6 (8.3) | 1 (5.6) | 5 (9.3) |
| Native Hawaiian/other Pacific Islander | 1 (1.4) | 0 | 1 (1.9) |
| American Indian/Alaska Native | 2 (2.8) | 0 | 2 (3.7) |
| White | 58 (80.6) | 14 (77.8) | 44 (81.5) |
| Ethnicityd | |||
| Hispanic or Latino | 7 (9.7) | 1 (5.6) | 6 (11.1) |
| Not Hispanic or Latino | 65 (90.3) | 17 (94.4) | 48 (88.9) |
| Underlying disease | |||
| Non-Hodgkin lymphoma | 52 (72.2) | 11 (61.1) | 41 (75.9) |
| ALL | 3 (4.2) | 0 | 3 (5.6) |
| CLL | 3 (4.2) | 1 (5.6) | 2 (3.7) |
| Multiple myeloma | 14 (19.4) | 6 (33.3) | 8 (14.8) |
| Prior treatments | |||
| Prior antitumor regimens, median (IQR), no. | 4 (3–6) | 5 (3–9) | 4 (3–5) |
| >6 Antitumor regimens (upper quartile) | 11 (15.3) | 6 (33.3) | 5 (9.3) |
| Prior HCT, any | 24 (33.3) | 5 (27.8) | 19 (35.2) |
| Prior allogeneic HCTe | 6 (8.3) | 3 (16.7) | 3 (5.6) |
| Prior HCT within 1 yf | 4 (5.6) | 0 | 4 (7.4) |
| Time since HCT, median (IQR), y | 4.2 (1.4, 5.9) | 5.2 (4.2, 7.7) | 3 (1.2, 5.8) |
| Prior CARTx | 4 (5.6) | 0 | 4 (7.4) |
| Antibody-based therapy within 6 mg | 43 (59.7) | 10 (55.6) | 33 (61.1) |
| Combination with targeted therapies | |||
| Bruton kinase inhibitorsh | 13 (18.1) | 3 (16.7) | 10 (18.5) |
| CAR T-cell target | |||
| CD19/CD20i | 58 (80.6) | 12 (66.7) | 46 (85.2) |
| BCMA | 14 (19.4) | 6 (33.3) | 8 (14.8) |
| CAR T-cell product | |||
| Axicabtagene ciloleucel | 15 (20.8) | 5 (27.8) | 10 (18.5) |
| Tisagenlecleucel | 3 (4.2) | 0 | 3 (5.6) |
| Lisocabtagene maraleucel | 21 (29.2) | 3 (16.7) | 18 (33.3) |
| Brexucabtagene autoleucel | 7 (9.7) | 1 (5.6) | 6 (11.1) |
| Idecabtagene vicleucel | 7 (9.7) | 3 (16.7) | 4 (7.4) |
| Ciltacabtagene autoleucel | 7 (9.7) | 3 (16.7) | 4 (7.4) |
| Investigational product | 12 (16.7) | 3 (16.7) | 9 (16.7) |
| ALC at baseline, median (IQR), cells/μLj | 690 (400–1080) | 710 (500–1240) | 670 (320–1010) |
| Lymphopenia (≤500 cells/μL) | 24 (33.3) | 5 (27.8) | 19 (35.2) |
| High CAR-HEMATOTOX scorek | 22 (30.6) | 5 (27.8) | 17 (31.5) |
| Post-CARTx clinical features | |||
| CRS, any | 54 (75) | 14 (77.8) | 40 (74.1) |
| Grade 0 | 18 (25) | 4 (22.2) | 14 (25.9) |
| Grade 1 | 29 (40.3) | 7 (38.9) | 22 (40.7) |
| Grade 2 | 24 (33.3) | 7 (38.9) | 17 (31.5) |
| Grade 3 | 1 (1.4) | 0 | 1 (1.9) |
| Grade 4 | 0 | 0 | 0 |
| ICANS, any | 29 (40.3) | 8 (44.4) | 21 (38.9) |
| Grade 0 | 43 (59.7) | 10 (55.6) | 33 (61.1) |
| Grade 1 | 8 (11.1) | 1 (5.6) | 7 (13.0) |
| Grade 2 | 7 (9.7) | 3 (16.7) | 4 (7.4) |
| Grade 3 | 12 (16.7) | 4 (22.2) | 8 (14.8) |
| Grade 4 | 2 (2.8) | 0 | 2 (3.7) |
| CRS and/or ICANS grade ≥2 | 32 (44.4) | 11 (61.1) | 21 (38.9) |
| Immunosuppression for CRS/ICANSl | 31 (43.1) | 11 (61.1) | 20 (37.0) |
| Corticosteroids only | 5 (6.9) | 1 (5.6) | 4 (7.4) |
| Tocilizumab only | 1 (1.4) | 0 | 1 (1.9) |
| Combination therapym | 25 (34.7) | 10 (55.6) | 15 (27.8) |
| Steroids, any | 30 (41.7) | 11 (61.1) | 19 (35.2) |
| High corticosteroid exposuren | 17 (23.6) | 7 (38.9) | 10 (18.5) |
| Duration of steroids, mean (SD), d | 2.9 (5.5) | 4.1 (5.2) | 2.4 (5.6) |
| >3 d of steroids | 17 (23.6) | 7 (38.9) | 10 (18.5) |
Abbreviations: ALC, absolute lymphocyte count; ALL, acute lymphoblastic leukemia; CAR, chimeric antigen receptor; CARTx, CAR-modified T-cell immunotherapy; CLL, chronic lymphoblastic leukemia; CRS, cytokine release syndrome; HCT, hematopoietic cell transplantation; ICANS, immune effector cell–associated neurotoxicity syndrome; IQR, interquartile range; SD, standard deviation.
aData represent no. (%) of patients, unless otherwise specified.
bThree patients received repeated infusions, for a total of 72 infusions in 69 patients.
cOne patient had pre–CAR–T-cell infusion CMV reactivation and is not included here.
dRace and ethnicity were self-identified.
eFour patients received allogeneic and autologous HCT.
fAll HCTs during the year before CAR–T-cell infusion were autologous.
gMonoclonal antibodies targeting B-cells within 6 months, including rituximab (n = 35), blinatumomab (n = 1), obinutuzumab (n = 2), polatuzumab vedotin (n = 11), inotuzumab ozogamicin (n = 1), daratumumab (n = 3), and belantamab (n = 1).
hAdministered within a month before CAR–T-cell therapy and including acalabrutinib (n = 8), ibrutinib (n = 2), pirtobrutinib (n = 1), and zanubrutinib (n = 2).
iCD20-targeted CAR-T cells in 8 patients (CMV reactivation, n = 3; no CMV reactivation, n = 5).
jLowest ALCs between days −14 and −5 (before lymphodepleting chemotherapy).
kData were available data for 59 patents, with high scores defined as scores ≥2.
lExcluding prophylactic anakinra as part of a trial in 8 patients (3 of whom required additional treatment for CRS/ICANS).
mCorticosteroids and tocilizumab (n = 17); corticosteroids, tocilizumab, and anakinra (n = 6); corticosteroids and anakinra (n = 2). One patient required high-dose corticosteroids, including intrathecal hydrocortisone, anakinra, and cetuximab (attempt to eliminate CAR–T-cell activity).
nMore than 3 days of dexamethasone at ≥10 mg/d within a 7-day period (and/or ≥1 dose of methylprednisolone at ≥1 g/d).