Patient characteristics
| Characteristic . | Group 1 (n = 11) . | Group 2 (n = 18) . | P . |
|---|---|---|---|
| JCAR014 dose level, n (%) | |||
| 1 (7.0 × 105/kg) | 2 (18) | 0 | |
| 2 (2.0 × 106/kg) | 9 (82) | 18 (100) | |
| Age | |||
| Median (IQR), y | 65 (59-67) | 58 (52-67) | .26 |
| ≥ 65 y, n (%) | 7 (64) | 6 (33) | .14 |
| Male sex, n (%) | 8 (73) | 11 (61) | .69 |
| ECOG performance score ≥ 1, n (%) | 6 (55) | 7 (39) | .47 |
| Disease histology, n (%) | |||
| DLBCL, NOS | 6 (55) | 7 (39) | .47 |
| DLBCL transformed from indolent histology | 4 (36) | 4 (22) | .43 |
| High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements | 1 (9) | 5 (28) | .36 |
| Other∗ | 0 | 2 (11) | .51 |
| MYC and BCL2 double-expressor† | |||
| Yes | 2 (20) | 2 (15) | 1 |
| No | 5 (50) | 6 (46) | 1 |
| Missing | 3 (30) | 5 (39) | 1 |
| Cell of origin (Hans algorithm), n (%) | |||
| Germinal center B-cell phenotype | 8 (73) | 9 (50) | .43 |
| Nongerminal-center B-cell phenotype | 3 (27) | 8 (44) | .43 |
| Missing | 0 | 1 (6) | 1 |
| Ann Arbor stage III or IV, n (%) | 10 (91) | 14 (78) | .62 |
| Extranodal disease, n (%) | 6 (55) | 12 (67) | .70 |
| LDH | |||
| Median (IQR), U/L | 227 (184-315) | 173 (149-343) | .29 |
| Elevated, n (%) | 7 (64) | 7 (39) | .26 |
| IPI, n (%)‡ | |||
| 0-2 | 5 (45) | 11 (61) | .47 |
| ≥ 3 | 6 (55) | 7 (39) | .47 |
| Tumor cross-sectional area, median (IQR), mm2§ | 4758 (2968-5475) | 3085 (984-6254) | .31 |
| Number of prior therapies, median (range) | 3 (2-7) | 2 (1-9) | .34 |
| Primary refractory disease, n (%) | 5 (45) | 8 (44) | 1 |
| Prior autologous hematopoietic stem cell transplantation, n (%) | 2 (18) | 3 (17) | 1 |
| Therapy between leukapheresis and lymphodepletion, n (%) | 4 (36) | 6 (33) | 1 |
| Characteristic . | Group 1 (n = 11) . | Group 2 (n = 18) . | P . |
|---|---|---|---|
| JCAR014 dose level, n (%) | |||
| 1 (7.0 × 105/kg) | 2 (18) | 0 | |
| 2 (2.0 × 106/kg) | 9 (82) | 18 (100) | |
| Age | |||
| Median (IQR), y | 65 (59-67) | 58 (52-67) | .26 |
| ≥ 65 y, n (%) | 7 (64) | 6 (33) | .14 |
| Male sex, n (%) | 8 (73) | 11 (61) | .69 |
| ECOG performance score ≥ 1, n (%) | 6 (55) | 7 (39) | .47 |
| Disease histology, n (%) | |||
| DLBCL, NOS | 6 (55) | 7 (39) | .47 |
| DLBCL transformed from indolent histology | 4 (36) | 4 (22) | .43 |
| High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements | 1 (9) | 5 (28) | .36 |
| Other∗ | 0 | 2 (11) | .51 |
| MYC and BCL2 double-expressor† | |||
| Yes | 2 (20) | 2 (15) | 1 |
| No | 5 (50) | 6 (46) | 1 |
| Missing | 3 (30) | 5 (39) | 1 |
| Cell of origin (Hans algorithm), n (%) | |||
| Germinal center B-cell phenotype | 8 (73) | 9 (50) | .43 |
| Nongerminal-center B-cell phenotype | 3 (27) | 8 (44) | .43 |
| Missing | 0 | 1 (6) | 1 |
| Ann Arbor stage III or IV, n (%) | 10 (91) | 14 (78) | .62 |
| Extranodal disease, n (%) | 6 (55) | 12 (67) | .70 |
| LDH | |||
| Median (IQR), U/L | 227 (184-315) | 173 (149-343) | .29 |
| Elevated, n (%) | 7 (64) | 7 (39) | .26 |
| IPI, n (%)‡ | |||
| 0-2 | 5 (45) | 11 (61) | .47 |
| ≥ 3 | 6 (55) | 7 (39) | .47 |
| Tumor cross-sectional area, median (IQR), mm2§ | 4758 (2968-5475) | 3085 (984-6254) | .31 |
| Number of prior therapies, median (range) | 3 (2-7) | 2 (1-9) | .34 |
| Primary refractory disease, n (%) | 5 (45) | 8 (44) | 1 |
| Prior autologous hematopoietic stem cell transplantation, n (%) | 2 (18) | 3 (17) | 1 |
| Therapy between leukapheresis and lymphodepletion, n (%) | 4 (36) | 6 (33) | 1 |
ECOG, Eastern Cooperative Oncology Group; IPI, International Prognostic Index; LDH, lactate dehydrogenase; NOS, not otherwise specified.
P values per Wilcoxon rank-sum test or Fisher exact test (2-sided), as appropriate.
One patient with primary mediastinal B-cell lymphoma and 1 patient with Richter transformation.
Excluding double- or triple-hit lymphoma (n = 23).
Scores on the IPI include low risk (0 or 1 point), low-intermediate risk (2 points), high-intermediate risk (3 points), and high risk (4 or 5 points).
Sum of the product of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites.