Patient characteristics
| . | Median (range), n = 21 . |
|---|---|
| Age, y | 33 (18-64) |
| Prior lines of therapy | 7 (4-15) |
| Baseline LDH∗ | 181 (112-469) |
| Number of patients (%) | |
| Male | 15 (71) |
| Female | 6 (29) |
| cHL | 20 (95) |
| Nodular sclerosis | 10 (48) |
| Histologic subtype not determined | 6 (29) |
| Mixed cellularity | 2 (9.5) |
| Lymphocyte rich | 2 (9.5) |
| Anaplastic large-cell lymphoma, ALK-negative | 1 (4.8) |
| Prior autologous stem cell transplantation | 14 (67) |
| Prior BV | 21 (100) |
| Prior immune checkpoint inhibitor | 18 (86) |
| Prior allogeneic stem cell transplantation | 3 (14) |
| Chemotherapy refractory† | 8 (40) |
| Refractory to BV‡ | 17 (94) |
| Cyclophosphamide dose (mg/m2) and CAR T-cell dose (CAR+T cells per kg)§ | |
| Cyclophosphamide 300 mg/m2 + 0.3 × 106 CAR+ T cells per kg | 3 (14) |
| Cyclophosphamide 300 mg/m2 + 1.0 × 106 CAR+ T cells per kg | 6 (29) |
| Cyclophosphamide 300 mg/m2 + 3.0 × 106 CAR+ T cells per kg | 3 (14) |
| Cyclophosphamide 500 mg/m2 + 3.0 × 106 CAR+ T cells per kg | 4 (19) |
| Cyclophosphamide 500 mg/m2 + 9.0 × 106 CAR+ T cells per kg | 5 (24) |
| Median (range), n = 21 | |
| Baseline MTV | 66.1 (6.4 - 486.7) |
| Number of patients (%) | |
| MTV > 60 mL | 11 (52) |
| . | Median (range), n = 21 . |
|---|---|
| Age, y | 33 (18-64) |
| Prior lines of therapy | 7 (4-15) |
| Baseline LDH∗ | 181 (112-469) |
| Number of patients (%) | |
| Male | 15 (71) |
| Female | 6 (29) |
| cHL | 20 (95) |
| Nodular sclerosis | 10 (48) |
| Histologic subtype not determined | 6 (29) |
| Mixed cellularity | 2 (9.5) |
| Lymphocyte rich | 2 (9.5) |
| Anaplastic large-cell lymphoma, ALK-negative | 1 (4.8) |
| Prior autologous stem cell transplantation | 14 (67) |
| Prior BV | 21 (100) |
| Prior immune checkpoint inhibitor | 18 (86) |
| Prior allogeneic stem cell transplantation | 3 (14) |
| Chemotherapy refractory† | 8 (40) |
| Refractory to BV‡ | 17 (94) |
| Cyclophosphamide dose (mg/m2) and CAR T-cell dose (CAR+T cells per kg)§ | |
| Cyclophosphamide 300 mg/m2 + 0.3 × 106 CAR+ T cells per kg | 3 (14) |
| Cyclophosphamide 300 mg/m2 + 1.0 × 106 CAR+ T cells per kg | 6 (29) |
| Cyclophosphamide 300 mg/m2 + 3.0 × 106 CAR+ T cells per kg | 3 (14) |
| Cyclophosphamide 500 mg/m2 + 3.0 × 106 CAR+ T cells per kg | 4 (19) |
| Cyclophosphamide 500 mg/m2 + 9.0 × 106 CAR+ T cells per kg | 5 (24) |
| Median (range), n = 21 | |
| Baseline MTV | 66.1 (6.4 - 486.7) |
| Number of patients (%) | |
| MTV > 60 mL | 11 (52) |
ALK, anaplastic lymphoma kinase; LDH, lactate dehydrogenase.
Most recent LDH before start of conditioning chemotherapy. Units are international units/L. The institutional upper limit of normal is 226 U/L.
Chemotherapy refractory is defined as best response to last therapy being SD or PD, or PD while receiving last therapy. Percentage calculated based on 20 evaluable patients. One patient had unknown response to last cytotoxic chemotherapy.
Refractory to BV was defined as best response to the last regimen containing BV being SD or PD. In addition, PD while receiving the last regimen containing BV was counted as refractory. Percentage calculated based on 18 evaluable patients. Three patients had unknown response to BV.
Because of low toxicity observed at the 0.3 × 106 CAR+ T cells per kg dose level, the protocol was amended to allow patients in cohort 2 to start dose escalation at the 1 × 106 CAR+ T cells per kg dose. Because of limited durability of responses observed on the first 3 dose levels, the protocol was amended to increase the dose of cyclophosphamide from 300 to 500 mg/m2, so that 3 patients received 3 × 106 CAR+ T cells per kg and cyclophosphamide 300 mg/m2, and 3 patients received 3 × 106 CAR+ T cells per kg and cyclophosphamide 500 mg/m2.