Patients, treatment, and product characteristics
| Variable . | Cohort 1 . | Cohort 2 . | Cohort 3 . |
|---|---|---|---|
| No. of patients enrolled | 32 | 10 | 15 |
| Time period | 2003-2007 | 2005 | 2010-2011 |
| Patient age in years (range) | 46 (7-68 y) | 37 (5-65 y) | 51 (3-71 y) |
| Patient gender (male) | 19 (59%) | 5 (50%) | 8 (55%) |
| Marrow blasts (mean %) | 45% (range 2-98) | 36% (range 7-92) | 34% (range 8-69) |
| Number of prior therapies (mean) | 4 | 3 | 3 |
| Prior HCT | 2 auto/4 allo | 0 | 0 |
| Recipient CMV+ status | 14 (44%) | 6 (60%) | 7 (45%) |
| Conditioning | Cy/Flu | Cy/Flu | Cy/Flu |
| No. of IL-2 doses (mean) | 4 (range 3-6) | 4 (range 3-6) | 4 (range 1-6) |
| IL2DT received | No | No | Yes* |
| KIR mismatch in GVHD direction | 6 (17%) | 5 (50%) | 8 (53%) |
| Product processing method | CD3- | CD3-CD56+ | CD3-CD19- |
| Final product characteristics | |||
| Dose of NC/kg | 2.5 ± 0.8 x107 | 0.44 ± 0.09 × 107 | 4.7 ± 1.8 × 107 |
| Dose of NK cells/kg infused | 0.96 ± 0.3 × 107 | 0.34 ± 0.05 x107 | 2.6 ± 1.5 × 107 |
| Percentage NK cells | 39 ± 9% | 75 ± 6% | 54 ± 16% |
| Dose of T-cells/kg | 14 × 104 | 6.2 × 104 | 9.7 × 104 |
| Percentage T cells | 0.7% | 1.3% | 0.3% |
| Variable . | Cohort 1 . | Cohort 2 . | Cohort 3 . |
|---|---|---|---|
| No. of patients enrolled | 32 | 10 | 15 |
| Time period | 2003-2007 | 2005 | 2010-2011 |
| Patient age in years (range) | 46 (7-68 y) | 37 (5-65 y) | 51 (3-71 y) |
| Patient gender (male) | 19 (59%) | 5 (50%) | 8 (55%) |
| Marrow blasts (mean %) | 45% (range 2-98) | 36% (range 7-92) | 34% (range 8-69) |
| Number of prior therapies (mean) | 4 | 3 | 3 |
| Prior HCT | 2 auto/4 allo | 0 | 0 |
| Recipient CMV+ status | 14 (44%) | 6 (60%) | 7 (45%) |
| Conditioning | Cy/Flu | Cy/Flu | Cy/Flu |
| No. of IL-2 doses (mean) | 4 (range 3-6) | 4 (range 3-6) | 4 (range 1-6) |
| IL2DT received | No | No | Yes* |
| KIR mismatch in GVHD direction | 6 (17%) | 5 (50%) | 8 (53%) |
| Product processing method | CD3- | CD3-CD56+ | CD3-CD19- |
| Final product characteristics | |||
| Dose of NC/kg | 2.5 ± 0.8 x107 | 0.44 ± 0.09 × 107 | 4.7 ± 1.8 × 107 |
| Dose of NK cells/kg infused | 0.96 ± 0.3 × 107 | 0.34 ± 0.05 x107 | 2.6 ± 1.5 × 107 |
| Percentage NK cells | 39 ± 9% | 75 ± 6% | 54 ± 16% |
| Dose of T-cells/kg | 14 × 104 | 6.2 × 104 | 9.7 × 104 |
| Percentage T cells | 0.7% | 1.3% | 0.3% |
CD3−, CD3 depletion; CD3−CD56+, CD3 depletion followed by CD56-positive selection; CD19−, CD19 negative selection; CMV, cytomegalovirus; NC, nucleated cell dose.
Doses of 12 to 18 μg/kg × 1 (n = 11) or 2 doses (n = 4) were used.