Patient and disease characteristics before CART2
| Characteristic . | Overall, N = 44 . | ALL, N = 14 . | CLL, N = 9 . | NHL, N = 21 . |
|---|---|---|---|---|
| Female | 8 (18%) | 5 (36%) | 1 (11%) | 2 (9.5%) |
| Age (y) | 58 (44, 62) | 45 (30, 56) | 60 (56, 64) | 61 (52, 67) |
| 23-73 | 23-62 | 41-73 | 29-70 | |
| No. of prior therapies* | 5 (4, 6) | 4 (3, 6) | 6 (5, 7) | 4 (3, 6) |
| 1-12 | 1-12 | 5-9 | 2-11 | |
| Prior autologous HCT | 9 (20%) | 0 (0%) | 1 (11%) | 8 (38%) |
| Prior allo-HCT | 14 (32%) | 10 (71%) | 2 (22%) | 2 (9.5%) |
| Time from last HCT to CART2 (mo) | 16 (12, 31) | 18 (12, 34) | 12 (10, 14) | 17 (13, 39) |
| 4-107 | 10-91 | 8-16 | 4-107 | |
| Time from CART1 to CART2 (d) | 70 (47, 308) | 102 (57, 212) | 61 (47, 320) | 50 (44, 307) |
| 28-712 | 34-548 | 29-712 | 28-687 | |
| Serum LDH (U/L) | 182 (154, 256) | 174 (139, 298) | 180 (145, 242) | 187 (158, 256) |
| 89-859 | 89-848 | 109-293 | 127-859 | |
| Cross-sectional tumor area (mm2)† | 2254 (589, 5511) | 576 (44, 907) | 5231 (3904, 6832) | 2372 (597, 5470) |
| 0-19179 | 0-1237 | 2136-15,460 | 318-19,179 | |
| Bulky disease (≥5 cm) | 17 (39%) | 1 (7%) | 6 (67%) | 10 (48%) |
| Abnormal B cells in marrow (% of WBC)‡ | 4 (0, 24) | 4 (0, 35) | 36 (19, 63) | 0 (0, 0) |
| 0-93 | 0-93 | 4-78 | 0-9 | |
| Abnormal B cells in blood (cells/µL)§ | 0 (0, 27) | 1 (0, 250) | 212 (41, 435) | 0 (0, 0) |
| 0-80,547 | 0-80,547 | 0-1830 | 0-24 | |
| Bridging therapy before CART2|| | 13 (30%) | 5 (36%) | 4 (44%) | 4 (19%) |
| CNS disease¶ | 3 (7.3%) | 1 (8.3%) | 1 (11%) | 1 (5.0%) |
| Indication for CART2 | ||||
| No response after CART1 | 15 (34%) | 3 (21%) | 6 (67%) | 6 (29%) |
| Partial response after CART1 | 7 (16%) | 1 (7.1%) | 0 (0%) | 6 (29%) |
| Relapse after CR post CART1 | 15 (34%) | 9 (64%) | 0 (0%) | 6 (29%) |
| Relapse after PR post CART1 | 7 (16%) | 1 (7.1%) | 3 (33%) | 3 (14%) |
| Tumor CD19 expression pre-CART2 | ||||
| Normal | 28 (64%) | 13 (93%) | 7 (78%) | 8 (38%) |
| Decreased | 3 (7%) | 0 (0%) | 0 (0%) | 3 (14%) |
| Not evaluated | 13 (29%) | 1 (7%) | 2 (22%) | 10 (48%) |
| Characteristic . | Overall, N = 44 . | ALL, N = 14 . | CLL, N = 9 . | NHL, N = 21 . |
|---|---|---|---|---|
| Female | 8 (18%) | 5 (36%) | 1 (11%) | 2 (9.5%) |
| Age (y) | 58 (44, 62) | 45 (30, 56) | 60 (56, 64) | 61 (52, 67) |
| 23-73 | 23-62 | 41-73 | 29-70 | |
| No. of prior therapies* | 5 (4, 6) | 4 (3, 6) | 6 (5, 7) | 4 (3, 6) |
| 1-12 | 1-12 | 5-9 | 2-11 | |
| Prior autologous HCT | 9 (20%) | 0 (0%) | 1 (11%) | 8 (38%) |
| Prior allo-HCT | 14 (32%) | 10 (71%) | 2 (22%) | 2 (9.5%) |
| Time from last HCT to CART2 (mo) | 16 (12, 31) | 18 (12, 34) | 12 (10, 14) | 17 (13, 39) |
| 4-107 | 10-91 | 8-16 | 4-107 | |
| Time from CART1 to CART2 (d) | 70 (47, 308) | 102 (57, 212) | 61 (47, 320) | 50 (44, 307) |
| 28-712 | 34-548 | 29-712 | 28-687 | |
| Serum LDH (U/L) | 182 (154, 256) | 174 (139, 298) | 180 (145, 242) | 187 (158, 256) |
| 89-859 | 89-848 | 109-293 | 127-859 | |
| Cross-sectional tumor area (mm2)† | 2254 (589, 5511) | 576 (44, 907) | 5231 (3904, 6832) | 2372 (597, 5470) |
| 0-19179 | 0-1237 | 2136-15,460 | 318-19,179 | |
| Bulky disease (≥5 cm) | 17 (39%) | 1 (7%) | 6 (67%) | 10 (48%) |
| Abnormal B cells in marrow (% of WBC)‡ | 4 (0, 24) | 4 (0, 35) | 36 (19, 63) | 0 (0, 0) |
| 0-93 | 0-93 | 4-78 | 0-9 | |
| Abnormal B cells in blood (cells/µL)§ | 0 (0, 27) | 1 (0, 250) | 212 (41, 435) | 0 (0, 0) |
| 0-80,547 | 0-80,547 | 0-1830 | 0-24 | |
| Bridging therapy before CART2|| | 13 (30%) | 5 (36%) | 4 (44%) | 4 (19%) |
| CNS disease¶ | 3 (7.3%) | 1 (8.3%) | 1 (11%) | 1 (5.0%) |
| Indication for CART2 | ||||
| No response after CART1 | 15 (34%) | 3 (21%) | 6 (67%) | 6 (29%) |
| Partial response after CART1 | 7 (16%) | 1 (7.1%) | 0 (0%) | 6 (29%) |
| Relapse after CR post CART1 | 15 (34%) | 9 (64%) | 0 (0%) | 6 (29%) |
| Relapse after PR post CART1 | 7 (16%) | 1 (7.1%) | 3 (33%) | 3 (14%) |
| Tumor CD19 expression pre-CART2 | ||||
| Normal | 28 (64%) | 13 (93%) | 7 (78%) | 8 (38%) |
| Decreased | 3 (7%) | 0 (0%) | 0 (0%) | 3 (14%) |
| Not evaluated | 13 (29%) | 1 (7%) | 2 (22%) | 10 (48%) |
Statistics presented: n (%); median (IQR) minimum-maximum.
Excluding prior HCT and CART1.
In patients with evaluable nodal disease (n = 30); sum of the product of the diameters of up to 6 of the largest lymph nodes or masses evaluated on the pre-CART2 lymphodepletion computed tomography scan.
In patients with evaluable marrow disease (n = 33).
Missing data in 2 patients.
Details of bridging regimens available in supplemental Table 2.
CNS disease was not evaluated in 3 patients because of low clinical suspicion. CD19 expression on tumor cells was evaluated by immunohistochemistry and/or flow cytometry.
CNS, central nervous system; LDH, lactate dehydrogenase; WBC, white blood cell.