Participant demographics and clinical characteristics
| . | Disease type* . | |||
|---|---|---|---|---|
| ALL . | CLL . | NHL . | Total . | |
| No. of patients | 8 (21) | 9 (23) | 22 (56) | 39 |
| Males | 4 (50) | 6 (67) | 16 (73) | 26 (67) |
| Race | ||||
| White | 8 (100) | 8 (89) | 20 (91) | 36 (91) |
| African American | 0 | 0 | 1 (4.5) | 1 (3) |
| American Indian | 0 | 0 | 1 (4.5) | 1 (3) |
| Unknown | 0 | 1 (11) | 0 | 1 (3) |
| Age, median (range), y | 44 (24-71) | 61 (53-73) | 57 (43-69) | 58 (24-73) |
| No. of prior chemotherapeutic regimens, median (range) | 4 (2-11) | 5 (3-9) | 4 (2-9) | 4 (2-11) |
| Anti-CD20 treatment within 6 mo pre-CARTx | 0 | 4 (44) | 9 (41) | 13 (33) |
| Received prior HCT | 6 (75) | 3 (33) | 12 (55) | 21 (54) |
| Days between last HCT and CAR T-cell infusion, median (range) | 1 002 (96-3670) | 2653 (797-4308) | 490 (156-8401) | 797 (96-8401) |
| Type of prior HCT | ||||
| None | 2 (25) | 6 (67) | 10 (46) | 18 (46) |
| Allogeneic only | 6 (75) | 3 (33) | 2 (9) | 11 (28) |
| Autologous only | 0 | 0 | 8 (36) | 8 (21) |
| Allogeneic and autologous | 0 | 0 | 2 (9) | 2 (5) |
| IgG pre-CARTx, mean (range), mg/dL† | 494 (155-1 056) | 398 (159-622) | 660 (245-1472) | 569 (155-1 472) |
| Cy/Flu lymphodepletion regimen‡ | 7 (88) | 9 (100) | 21 (95) | 37 (95) |
| CD19-directed CAR T-cell dose, cells per kg | ||||
| ∼2 × 105 (dose level 1) | 2 (25) | 1 (11) | 0 | 3 (8) |
| ∼2 × 106 (dose level 2) | 5 (62.5) | 8 (89) | 21 (95) | 34 (87) |
| ∼2 × 107 (dose level 3) | 1 (12.5) | 0 | 1 (5) | 2 (5) |
| CRS grade§ | ||||
| 0 | 1 (12.5) | 3 (33.4) | 8 (36.4) | 12 (30.8) |
| 1 | 1 (12.5) | 2 (22.2) | 7 (31.8) | 10 (25.6) |
| 2 | 1 (12.5) | 2 (22.2) | 5 (22.7) | 8 (20.5) |
| 3 | 4 (50) | 2 (22.2) | 0 | 6 (15.4) |
| 4 | 1 (12.5) | 0 | 2 (9.1) | 3 (7.7) |
| . | Disease type* . | |||
|---|---|---|---|---|
| ALL . | CLL . | NHL . | Total . | |
| No. of patients | 8 (21) | 9 (23) | 22 (56) | 39 |
| Males | 4 (50) | 6 (67) | 16 (73) | 26 (67) |
| Race | ||||
| White | 8 (100) | 8 (89) | 20 (91) | 36 (91) |
| African American | 0 | 0 | 1 (4.5) | 1 (3) |
| American Indian | 0 | 0 | 1 (4.5) | 1 (3) |
| Unknown | 0 | 1 (11) | 0 | 1 (3) |
| Age, median (range), y | 44 (24-71) | 61 (53-73) | 57 (43-69) | 58 (24-73) |
| No. of prior chemotherapeutic regimens, median (range) | 4 (2-11) | 5 (3-9) | 4 (2-9) | 4 (2-11) |
| Anti-CD20 treatment within 6 mo pre-CARTx | 0 | 4 (44) | 9 (41) | 13 (33) |
| Received prior HCT | 6 (75) | 3 (33) | 12 (55) | 21 (54) |
| Days between last HCT and CAR T-cell infusion, median (range) | 1 002 (96-3670) | 2653 (797-4308) | 490 (156-8401) | 797 (96-8401) |
| Type of prior HCT | ||||
| None | 2 (25) | 6 (67) | 10 (46) | 18 (46) |
| Allogeneic only | 6 (75) | 3 (33) | 2 (9) | 11 (28) |
| Autologous only | 0 | 0 | 8 (36) | 8 (21) |
| Allogeneic and autologous | 0 | 0 | 2 (9) | 2 (5) |
| IgG pre-CARTx, mean (range), mg/dL† | 494 (155-1 056) | 398 (159-622) | 660 (245-1472) | 569 (155-1 472) |
| Cy/Flu lymphodepletion regimen‡ | 7 (88) | 9 (100) | 21 (95) | 37 (95) |
| CD19-directed CAR T-cell dose, cells per kg | ||||
| ∼2 × 105 (dose level 1) | 2 (25) | 1 (11) | 0 | 3 (8) |
| ∼2 × 106 (dose level 2) | 5 (62.5) | 8 (89) | 21 (95) | 34 (87) |
| ∼2 × 107 (dose level 3) | 1 (12.5) | 0 | 1 (5) | 2 (5) |
| CRS grade§ | ||||
| 0 | 1 (12.5) | 3 (33.4) | 8 (36.4) | 12 (30.8) |
| 1 | 1 (12.5) | 2 (22.2) | 7 (31.8) | 10 (25.6) |
| 2 | 1 (12.5) | 2 (22.2) | 5 (22.7) | 8 (20.5) |
| 3 | 4 (50) | 2 (22.2) | 0 | 6 (15.4) |
| 4 | 1 (12.5) | 0 | 2 (9.1) | 3 (7.7) |
Data are n (%), unless otherwise indicated. Percentages represent column percentages, with the exception of “No. of patients,” which indicate row percentages.
Cy, cyclophosphamide; Flu, fludarabine.
The original cohort of treated patients consisted of 166 individuals: 57 had ALL, 44 had CLL, and 65 had NHL. A higher proportion of patients with ALL did not meet criteria for this study because of allogeneic HCT after achieving a CR post-CARTx, which is the standard of care at Fred Hutchinson Cancer Research Center.
Based on results for 32 participants with IgG concentration measured >16 weeks after IVIG and pre-CARTx.
Regimens included Cy 60 mg/kg × 1 day and Flu 25 mg/m2 × 3 days (n = 27); Cy 30 mg/kg × 1 day and Flu 25 mg/m2 × 3 days (n = 1); Cy 300 mg/m2 × 3 days and Flu 30 mg/m2 × 3 days (n = 6); Cy 3 g/m2 × 1 day and Flu 25 mg/m2 × 3 days (n = 1); Cy 500 mg/m2 × 3 days and Flu 30 mg/m2 × 3 days (n = 1); Cy 1 g/m2 × 1 day and Flu 25 mg/m2 × 3 days (n = 1); Cy 4 g/m2 × 1 day and etoposide 200 mg/m2 × 3 days (n = 1); and Cy 2 g/m2 × 1 day (n = 1).
Based on modified Lee criteria.6,33