Table 2.
T-cell infusions
Patient | Infusion 1, cells/m2* | Infusion 2, cells/m2† | Infusion 3, cells/m2‡ | Fresh versus thawed cells | Time from apheresis to target cell number, d | No. of stimulation cycles§ |
---|---|---|---|---|---|---|
A | 108 | 109 | 3.3 × 109 | Fresh | 130 | 7 |
B | 108 | 109 | 2 × 109 | Fresh | 129+ | 7 |
C | Expansion failed | 5 | ||||
D | 108 | 4 × 108 | Thawed | 159+ | 7 | |
E | Expansion failed | 5 | ||||
F | 108 | 109 | 3.3 × 109 | Thawed | 96 | 6 |
G | 108 | 109 | 3.3 × 109 | Thawed | 90 | 5 |
H | 108 | 109 | 3.3 × 109 | Thawed | 81 | 5 |
I | 108 | 109 | 2 × 109‖ | Thawed | 104 | 8 |
For patients A through E, T cells were selected and expanded by limiting dilution. For patients F through I, T cells were expanded in bulk culture. Patients C and E did not receive T-cell infusions. Patients B and D received infusions but did not reach the target cell dose.
Target dose was 108 cells/m2.
Target dose was 109 cells/m2.
Target dose was 3.3 × 109 cells/m2.
Defined as the number of times cells were stimulated with OKT3 in the presence of irradiated feeder PBMCs and LCL (repeated every 14 days, first cycle at day 14).
The target number of cells was generated for this patient, but nearly half of the last cell dose was lost during a quality control assay before infusion.