Table 1.
Clinical and treatment characteristics
| ALL, n = 47* | CLL, n = 24 | NHL, n = 62 | Total, N = 133 | |
|---|---|---|---|---|
| Baseline characteristics | ||||
| Age, median (range), y | 40 (20, 73) | 61 (40, 73) | 58 (28, 70) | 54 (20, 73) |
| Female | 20 (42.6) | 7 (29.2) | 13 (21.0) | 40 (30.1) |
| White | 35 (74.5) | 21 (87.5) | 54 (87.1) | 110 (82.7) |
| Prior antitumor treatment regimens, median (range) | 3 (1, 11) | 5 (3, 9) | 4 (1, 11) | 4 (1, 11) |
| Prior autologous and/or allogeneic HCT† | 17 (36.2) | 4 (16.7) | 29 (46.8) | 50 (37.6) |
| IgG <400 mg/dL prelymphodepletion‡ | 13 (28.9) | 8 (40.0) | 13 (22.8) | 34 (25.6) |
| ALC <200 prelymphodepletion | 40 (85.1) | 12 (50.0) | 54 (87.1) | 106 (79.7) |
| ANC <500 prelymphodepletion§ | 9 (20.0) | 2 (8.3) | 5 (8.8) | 16 (12.7) |
| Treatment | ||||
| Cy/Flu lymphodepletion regimen|| | 34 (72.3) | 21 (87.5) | 49 (79.0) | 104 (78.2) |
| CAR–T-cell dose | ||||
| 2 × 105 cells per kg, level 1 | 26 (55.3) | 4 (16.7) | 5 (8.1) | 35 (26.3) |
| 2 × 106 cells per kg, level 2 | 19 (40.4) | 19 (79.2) | 48 (77.4) | 86 (64.7)¶ |
| 2 × 107 cells per kg, level 3 | 2 (4.3) | 1 (4.2) | 9 (14.5) | 12 (9.0) |
| Post-CAR–T-cell characteristics | ||||
| Time-to neutrophil recovery ≥500, median (range), d# | 6 (1, 25) | 6 (3, 19) | 5 (1, 17) | 6 (1, 25) |
| CRS grade | ||||
| 0 | 12 (25.5) | 4 (16.7) | 24 (38.7) | 40 (30.1) |
| 1-3 | 31 (66.0) | 18 (75.0) | 34 (54.8) | 83 (62.4) |
| 4-5 | 4 (8.5) | 2 (8.3) | 4 (6.5) | 10 (7.5) |
| Neurotoxicity grade | ||||
| 0 | 22 (46.8) | 16 (66.7) | 42 (67.7) | 80 (60.2) |
| 1-2 | 11 (23.4) | 2 (8.3) | 12 (19.4) | 25 (18.8) |
| 3-5 | 14 (29.8) | 6 (25.0) | 8 (12.9) | 28 (21.1) |
| Corticosteroids and/or tocilizumab** | 15 (31.9) | 6 (25.0) | 7 (11.3) | 28 (21.1) |
| ICU admission by d 28 | 9 (19.1) | 2 (8.3) | 9 (14.5) | 20 (15.0) |
Data are presented as no. (%) unless otherwise specified. Lymphocyte and neutrophil counts are in units of cells per mm3.
ALC, absolute lymphocyte count; Cy, cytarabine; Flu, fludarabine; HCT, hematopoietic cell transplant; IQR, interquartile range.
One patient who received a second cycle of lymphodepletion chemotherapy and CAR–T-cell infusion following an allogeneic HCT performed after the first cycle of lymphodepletion and CAR–T-cell infusion is included as 2 separate enrollments.
Twenty-five patients (18.8%) had a prior allogeneic HCT alone, 22 (16.5%) had a prior autologous HCT alone, and 3 patients (2.3%) with NHL had both.
n = 122.
n = 126.
Regimens included: Cy 30 to 60 mg/kg IV on day 1 and Flu 25 mg/m2 per day IV on either days 2 to 4 or days 2 to 6 (Cy/Flu) (n = 100); Cy 2 to 4 g/m2 IV on day 1 (n = 17); Cy 2 to 4 g/m2 IV on day 1 and etoposide 200 mg/m2 per day IV on days 2 to 4 (n = 9); Cy 300 to 500 mg/m2 with Flu 30 mg/m2 concurrently for 3 days (n = 3); Flu 25 mg/m2 on days 1 to 3 (n = 2); Cy 1 g/m2 IV on day 1 and Flu 25 mg/m2 on days 2 to 4 (n = 1); bendamustine 90 mg/m2 for 2 days (n = 1). CAR T cells were infused in most patients between 36 and 96 hours after completion of chemotherapy.
Fifteen patients (NHL, n = 14; CLL, n = 1) received a second CAR–T-cell infusion ∼14 days after the first infusion and without additional lymphodepletion chemotherapy.
Time-to-neutrophil recovery was determined from the first day on or after CAR–T-cell infusion that a patient had an ANC < 500 cells per mm3 until the first of 3 consecutive days with an ANC ≥ 500 cells per mm3. Patients who did not reach an ANC ≥ 500 (ALL, n = 9; CLL, n = 7; NHL, n = 4) or never had an ANC < 500 (ALL, n = 7; CLL, n = 2; NHL, n = 5) were excluded from this analysis.
One patient received only tocilizumab, 7 received only corticosteroids, and 20 received both.