Patient demographics
| Subject ID . | Age at infusion, y . | Diagnosis . | Disease response . | Onset of CD19+ B-cell aplasia* . | Duration of CD19+ B-cell aplasia . | Pre-CART19 chemotherapy† . | Prophylactic immunoglobulin start, schedule . |
|---|---|---|---|---|---|---|---|
| UPN-1 | 64 | CLL | CR | Day +24‡ | To day +1827, last time point tested | Pentostatin/ Cyclophosphamide | IVIg day +259, then Q3-4 mo |
| UPN-2 | 60 | CLL | CR→ deceased (PR)§ | Day +11 | To day +428 | Pentostatin/ Cyclophosphamide | IVIg day +288, then monthly |
| UPN-3 | 55 | ALL | CR | Day +29 | To day +741, last time point tested | Cyclophosphamide/ Vincristine | IVIg on day +223, once |
| UPN-4 | 44 | FL | CR | Day −1 | To day +234 (day of death) | Fludarabine/ Cyclophosphamide | IVIg monthly, started >5 y prior to CTL019 |
| CHP-1 | 21 | ALL | CR→ deceased with sCD19− relapse | Day −1 | To day +261 (time of relapse) | Fludarabine/ Cyclophosphamide | IVIg day +126, then monthly |
| CHP-2 | 9 | ALL | CR | Day 0 | To day +735, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +2, then monthly, then switched to weekly subQ from day +255 |
| CHP-3 | 15 | ALL | CR | Day −1 | To day +745, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +35, then monthly, then switched to Q2 wk subQ from day +400 |
| CHP-4 | 9 | ALL | CR | Day −1 | To day +629, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +30, then monthly, then switched to weekly subQ from month +16 |
| CHP-5 | 22 | ALL | CR→ relapse (CD19− on day +687) | Day −2 | To day +250, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +2, then monthly |
| CHP-6 | 16 | ALL | CR | Day −1 | To day +642, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +7, then monthly, then switched to weekly subQ from day +548 |
| CHP-7 | 21 | ALL | CR | Day −1 | To day +640, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +18, then monthly |
| CHP-8 | 5 | ALL | CR | Day +1 | To day +647, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +17, then monthly, then switched to weekly subQ from day +630 |
| CHP-9 | 13 | ALL | CR→ relapse (CD19−) | Day −1 | To day +268, (time of relapse) | Fludarabine/ Cyclophosphamide | IVIg day +8, then monthly |
| CHP-10 | 19 | ALL | CR | Day −2 | To day +545, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +146, then monthly |
| CHP-11 | 9 | ALL | CR→ Allo Txp in CR | Day −1 | To day +93 → Allo Txp in CR | Fludarabine/ Cyclophosphamide | IVIg day +24, then monthly |
| CHP-12 | 17 | ALL | CR | Day −1 | To day +500, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +7, then monthly |
| Subject ID . | Age at infusion, y . | Diagnosis . | Disease response . | Onset of CD19+ B-cell aplasia* . | Duration of CD19+ B-cell aplasia . | Pre-CART19 chemotherapy† . | Prophylactic immunoglobulin start, schedule . |
|---|---|---|---|---|---|---|---|
| UPN-1 | 64 | CLL | CR | Day +24‡ | To day +1827, last time point tested | Pentostatin/ Cyclophosphamide | IVIg day +259, then Q3-4 mo |
| UPN-2 | 60 | CLL | CR→ deceased (PR)§ | Day +11 | To day +428 | Pentostatin/ Cyclophosphamide | IVIg day +288, then monthly |
| UPN-3 | 55 | ALL | CR | Day +29 | To day +741, last time point tested | Cyclophosphamide/ Vincristine | IVIg on day +223, once |
| UPN-4 | 44 | FL | CR | Day −1 | To day +234 (day of death) | Fludarabine/ Cyclophosphamide | IVIg monthly, started >5 y prior to CTL019 |
| CHP-1 | 21 | ALL | CR→ deceased with sCD19− relapse | Day −1 | To day +261 (time of relapse) | Fludarabine/ Cyclophosphamide | IVIg day +126, then monthly |
| CHP-2 | 9 | ALL | CR | Day 0 | To day +735, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +2, then monthly, then switched to weekly subQ from day +255 |
| CHP-3 | 15 | ALL | CR | Day −1 | To day +745, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +35, then monthly, then switched to Q2 wk subQ from day +400 |
| CHP-4 | 9 | ALL | CR | Day −1 | To day +629, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +30, then monthly, then switched to weekly subQ from month +16 |
| CHP-5 | 22 | ALL | CR→ relapse (CD19− on day +687) | Day −2 | To day +250, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +2, then monthly |
| CHP-6 | 16 | ALL | CR | Day −1 | To day +642, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +7, then monthly, then switched to weekly subQ from day +548 |
| CHP-7 | 21 | ALL | CR | Day −1 | To day +640, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +18, then monthly |
| CHP-8 | 5 | ALL | CR | Day +1 | To day +647, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +17, then monthly, then switched to weekly subQ from day +630 |
| CHP-9 | 13 | ALL | CR→ relapse (CD19−) | Day −1 | To day +268, (time of relapse) | Fludarabine/ Cyclophosphamide | IVIg day +8, then monthly |
| CHP-10 | 19 | ALL | CR | Day −2 | To day +545, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +146, then monthly |
| CHP-11 | 9 | ALL | CR→ Allo Txp in CR | Day −1 | To day +93 → Allo Txp in CR | Fludarabine/ Cyclophosphamide | IVIg day +24, then monthly |
| CHP-12 | 17 | ALL | CR | Day −1 | To day +500, last time point tested | Fludarabine/ Cyclophosphamide | IVIg day +7, then monthly |
Allo Txp, allogeneic bone marrow transplant; PR, partial response; Q, every; sCD19, surface-CD19; subQ, subcutaneous.
B-cell aplasia was defined as CD19+ B cells <1% of peripheral blood mononuclear cells. In the majority of samples, the percentage was 0% to 0.1%.
Chemotherapy aimed at lymphodepletion was given within 1 wk prior to CTL019 infusion, timed so that the last dose was given 2 to 6 d prior to infusion.
First postinfusion flow cytometry assessment, true onset of B-cell aplasia may be earlier.
UPN-2 was considered CR at month 6, then PR at month 14 based on radiology findings (at month 14, neither B cells nor CLL was detected in blood and bone marrow).