Patient characteristics and outcomes
| Characteristic . | All patients (n = 46 treatments; 43 patients) . | LBCL (n = 28 patients) . | Low-grade lymphoma (n = 10 treatments; 8 patients) . | CLL (n = 8 treatments; 7 patients) . | All patients with a response of CR (n = 25 treatments; 22 patients) . |
|---|---|---|---|---|---|
| Patient characteristics∗ | |||||
| Age at cell infusion, median (range), y | 54 (28-68) | 51 (28-67) | 56 (47-66) | 61 (48-68) | 61 (42-67) |
| Females at birth, (%) | 10 (23) | 8 (29) | 2 (25) | 0 (0) | 7 (32) |
| Prior lines of therapy, median (range) | 4 (1-12) | 4 (2-12) | 4 (1-7) | 4 (1-7) | 4 (1-10) |
| Baseline SPD, median (range), cm2†,‡ | 36.56 (1.72-378.81) | 36.56 (1.72-129.63) | 31.96 (12.07-378.81) | 46.20 (4.36-84.29) | 27.46 (4.36-129.63) |
| Chemotherapy refractory,§ n (%) | 21 (49) | 19 (68) | 0 (0) | 2 (29) | 10 (45) |
| Prior ASCT, n (%) | 13 (30) | 10 (36) | 3 (38) | 0 (0) | 7 (32) |
| Adverse events, n (%)† | |||||
| CRS grade 0 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| CRS grade 1-2 | 33 (72) | 23 (82) | 7 (70) | 3 (38) | 18 (72) |
| CRS grade 3-4 | 13 (28) | 5 (18) | 3 (30) | 5 (63) | 7 (28) |
| Neurotoxicity grade 0-1 | 17 (37) | 9 (32) | 4 (40) | 4 (50) | 5 (20) |
| Neurotoxicity grade 2 | 9 (20) | 7 (25) | 0 (0) | 2 (25) | 5 (20) |
| Neurotoxicity grade 3-4 | 20 (43) | 12 (43) | 6 (60) | 2 (25) | 15 (60) |
| Late ICAHT grade 0|| | 26 (70) | 11 (55) | 9 (100) | 6 (75) | 16 (67) |
| Late ICAHT grade 1|| | 5 (14) | 4 (20) | 0 (0) | 1 (13) | 3 (13) |
| Late ICAHT grade 2|| | 6 (16) | 5 (25) | 0 (0) | 1 (13) | 5 (21) |
| CAR T-cell kinetics and antimalignancy responses† | |||||
| Peak blood CAR-positive cells in cells per μL; median (range) | 42 (0-1217); (3 NE) | 39.5 (4-777) | 115 (1-1217); (3 NE) | 39 (0-821) | 86 (2-1217); (1 NE) |
| ORR, %¶ | 81% | 73% | 100% | 88% | 100% |
| CR, %¶ | 58% | 54% | 67% | 63% | 100% |
| Characteristic . | All patients (n = 46 treatments; 43 patients) . | LBCL (n = 28 patients) . | Low-grade lymphoma (n = 10 treatments; 8 patients) . | CLL (n = 8 treatments; 7 patients) . | All patients with a response of CR (n = 25 treatments; 22 patients) . |
|---|---|---|---|---|---|
| Patient characteristics∗ | |||||
| Age at cell infusion, median (range), y | 54 (28-68) | 51 (28-67) | 56 (47-66) | 61 (48-68) | 61 (42-67) |
| Females at birth, (%) | 10 (23) | 8 (29) | 2 (25) | 0 (0) | 7 (32) |
| Prior lines of therapy, median (range) | 4 (1-12) | 4 (2-12) | 4 (1-7) | 4 (1-7) | 4 (1-10) |
| Baseline SPD, median (range), cm2†,‡ | 36.56 (1.72-378.81) | 36.56 (1.72-129.63) | 31.96 (12.07-378.81) | 46.20 (4.36-84.29) | 27.46 (4.36-129.63) |
| Chemotherapy refractory,§ n (%) | 21 (49) | 19 (68) | 0 (0) | 2 (29) | 10 (45) |
| Prior ASCT, n (%) | 13 (30) | 10 (36) | 3 (38) | 0 (0) | 7 (32) |
| Adverse events, n (%)† | |||||
| CRS grade 0 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| CRS grade 1-2 | 33 (72) | 23 (82) | 7 (70) | 3 (38) | 18 (72) |
| CRS grade 3-4 | 13 (28) | 5 (18) | 3 (30) | 5 (63) | 7 (28) |
| Neurotoxicity grade 0-1 | 17 (37) | 9 (32) | 4 (40) | 4 (50) | 5 (20) |
| Neurotoxicity grade 2 | 9 (20) | 7 (25) | 0 (0) | 2 (25) | 5 (20) |
| Neurotoxicity grade 3-4 | 20 (43) | 12 (43) | 6 (60) | 2 (25) | 15 (60) |
| Late ICAHT grade 0|| | 26 (70) | 11 (55) | 9 (100) | 6 (75) | 16 (67) |
| Late ICAHT grade 1|| | 5 (14) | 4 (20) | 0 (0) | 1 (13) | 3 (13) |
| Late ICAHT grade 2|| | 6 (16) | 5 (25) | 0 (0) | 1 (13) | 5 (21) |
| CAR T-cell kinetics and antimalignancy responses† | |||||
| Peak blood CAR-positive cells in cells per μL; median (range) | 42 (0-1217); (3 NE) | 39.5 (4-777) | 115 (1-1217); (3 NE) | 39 (0-821) | 86 (2-1217); (1 NE) |
| ORR, %¶ | 81% | 73% | 100% | 88% | 100% |
| CR, %¶ | 58% | 54% | 67% | 63% | 100% |
ORR is the sum of partial and complete remissions.
ASCT, autologous stem cell transplant; ICAHT, immune effector cell–associated hematotoxicity; NE, not evaluable; ORR, overall response rate; SPD, sum of the products of the diameters of target lymph nodes.
For 3 patients who received retreatment, only the first treatment is included, unless otherwise specified. Sample size for patient characteristics is 43 for all patients, 28 for LBCL, 8 for low-grade lymphoma (follicular, n = 5; marginal zone, n = 2; mantle cell, n = 1), 7 for CLL, and 22 for patients achieving CR.
All treatments included for a total of 46 treatments: 28 LBCL, 10 low-grade lymphoma, 8 CLL, and 25 treatments resulting in CR.
One patient with low-grade lymphoma not evaluable.
Chemotherapy refractory was defined as failure to achieve CR or partial remission after the most recent therapy for patients with LBCL or low-grade lymphoma; chemotherapy refractory was defined as progression within 6 months after fludarabine administration for patients with CLL.
No patients had grade 3 to 4 late ICAHT. Eight treatments of patients with LBCL and 1 treatment of a patient with low-grade lymphoma were not evaluable for grading of late ICAHT, due to less than 2 months of follow-up after CAR T-cell infusion without new antimalignancy therapy.
Response rates exclude 3 treatments in which patients were not evaluable for response.