Baseline demographic and clinical characteristics of the patients
| Characteristics . | Patients (n = 28) . | Patients, leukapheresis (n = 33) . |
|---|---|---|
| Age, y | ||
| <60 | 21 (75) | 25 (76) |
| ≥60 | 7 (25) | 8 (24) |
| Sex | ||
| Male | 11 (39) | 12 (36) |
| Female | 17 (61) | 21 (64) |
| ECOG performance status score | ||
| 0-1 | 15 (54) | 20 (61) |
| 2 | 13 (46) | 13 (39) |
| Disease stage at study entry | ||
| I/II | 5 (18) | 6 (18) |
| III/IV | 23 (82) | 27 (82) |
| Diagnosis by central histologic review | ||
| DLBCL | 16 (57) | 19 (58) |
| TFL | 3 (11) | 4 (12) |
| FL | 6 (21) | 6 (18) |
| Other (MCL, CLL/SLL) | 3 (11) | 4 (12) |
| IHC | ||
| CD20+ | 28 (100) | 33 (100) |
| CD19+ | 22 (79) | 27 (82) |
| CD19− | 4 (14) | 4 (12) |
| Missing CD19 data | 2 (7) | 2 (6) |
| Double or triple expressor: MYC plus BCL2 or BCL6 or both | ||
| Yes | 10 (36) | 13 (39) |
| No | 4 (14) | 6 (18) |
| Missing data | 14 (50) | 14 (43) |
| Ki-67 (≥70%) | 18 (64) | 21 (64) |
| Extranodal organ involvement | ||
| Yes | 17 (61) | 20 (61) |
| No | 11 (39) | 13 (39) |
| No. of previous lines of antineoplastic therapy | ||
| ≤2 | 6 (21) | 7 (21) |
| 3-5 | 15 (54) | 18 (55) |
| ≥6 | 7 (25) | 8 (24) |
| Patient with chronic viral hepatitis B | ||
| Yes | 3 (11) | 4 (12) |
| No | 25 (89) | 29 (88) |
| Refractory or relapse | ||
| Refractory | 24 (86) | 28 (85) |
| Primary refractory* | 9 (32) | 11 (33) |
| Refractory to second-line or later therapy | 15 (54) | 18 (55) |
| Relapse after second-line or later therapy | 4 (14) | 5 (15) |
| Refractory to ASCT† | 5 (18) | 5 (15) |
| Relapse after previous CD19 CAR T-cell therapy‡ | 3 (11) | 3 (9) |
| Tumor burden | ||
| SPD ≥100 cm2 | 7 (25) | 10 (30) |
| SPD <100 cm2 | 21 (75) | 23 (70) |
| Bulky/nonbulky disease | ||
| Lesion diameter ≥10 cm | 5 (18) | 7 (21) |
| Lesion diameter <10 cm | 23 (82) | 26 (79) |
| Characteristics . | Patients (n = 28) . | Patients, leukapheresis (n = 33) . |
|---|---|---|
| Age, y | ||
| <60 | 21 (75) | 25 (76) |
| ≥60 | 7 (25) | 8 (24) |
| Sex | ||
| Male | 11 (39) | 12 (36) |
| Female | 17 (61) | 21 (64) |
| ECOG performance status score | ||
| 0-1 | 15 (54) | 20 (61) |
| 2 | 13 (46) | 13 (39) |
| Disease stage at study entry | ||
| I/II | 5 (18) | 6 (18) |
| III/IV | 23 (82) | 27 (82) |
| Diagnosis by central histologic review | ||
| DLBCL | 16 (57) | 19 (58) |
| TFL | 3 (11) | 4 (12) |
| FL | 6 (21) | 6 (18) |
| Other (MCL, CLL/SLL) | 3 (11) | 4 (12) |
| IHC | ||
| CD20+ | 28 (100) | 33 (100) |
| CD19+ | 22 (79) | 27 (82) |
| CD19− | 4 (14) | 4 (12) |
| Missing CD19 data | 2 (7) | 2 (6) |
| Double or triple expressor: MYC plus BCL2 or BCL6 or both | ||
| Yes | 10 (36) | 13 (39) |
| No | 4 (14) | 6 (18) |
| Missing data | 14 (50) | 14 (43) |
| Ki-67 (≥70%) | 18 (64) | 21 (64) |
| Extranodal organ involvement | ||
| Yes | 17 (61) | 20 (61) |
| No | 11 (39) | 13 (39) |
| No. of previous lines of antineoplastic therapy | ||
| ≤2 | 6 (21) | 7 (21) |
| 3-5 | 15 (54) | 18 (55) |
| ≥6 | 7 (25) | 8 (24) |
| Patient with chronic viral hepatitis B | ||
| Yes | 3 (11) | 4 (12) |
| No | 25 (89) | 29 (88) |
| Refractory or relapse | ||
| Refractory | 24 (86) | 28 (85) |
| Primary refractory* | 9 (32) | 11 (33) |
| Refractory to second-line or later therapy | 15 (54) | 18 (55) |
| Relapse after second-line or later therapy | 4 (14) | 5 (15) |
| Refractory to ASCT† | 5 (18) | 5 (15) |
| Relapse after previous CD19 CAR T-cell therapy‡ | 3 (11) | 3 (9) |
| Tumor burden | ||
| SPD ≥100 cm2 | 7 (25) | 10 (30) |
| SPD <100 cm2 | 21 (75) | 23 (70) |
| Bulky/nonbulky disease | ||
| Lesion diameter ≥10 cm | 5 (18) | 7 (21) |
| Lesion diameter <10 cm | 23 (82) | 26 (79) |
All data are n (%).
ASCT, allogeneic stem cell transplantation; DLBCL, diffuse large B-cell lymphoma; ECOG, Eastern Cooperative Oncology Group; FL, follicular lymphoma; IHC, immunohistochemistry; MCL, mantle cell lymphoma; SPD, sum of the products of the longest perpendicular diameters; TFL, transformed follicular lymphoma.
Defined as ≥1 of the following: no response to first-line therapy (primary refractory disease); subjects who did not tolerate first-line therapy chemotherapy were excluded. PD was the best response to first-line therapy, and stable disease was the best response after ≥4 cycles of first-line therapy (eg, 4 cycles of R-CHOP [rituximab, cyclophosphamide, adriamycin, vincristine, prednisone]) with stable disease for ≤6 months from the last treatment dose.
Defined as disease progression or relapse ≤12 months after ASCT (biopsy-proven recurrence required for relapsed subjects).
Defined as disease progression or relapse ≤6 months after previous CD19 CAR T-cell therapy (biopsy-proven recurrence required for relapsed subjects).