Table 1

Patients, treatment, and product characteristics

VariableCohort 1Cohort 2Cohort 3
No. of patients enrolled321015
Time period2003-200720052010-2011
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)433
Prior HCT2 auto/4 allo00
Recipient CMV+ status14 (44%)6 (60%)7 (45%)
ConditioningCy/FluCy/FluCy/Flu
No. of IL-2 doses (mean)4 (range 3-6)4 (range 3-6)4 (range 1-6)
IL2DT receivedNoNoYes*
KIR mismatch in GVHD direction6 (17%)5 (50%)8 (53%)
Product processing methodCD3-CD3-CD56+CD3-CD19-
Final product characteristics
Dose of NC/kg2.5 ± 0.8 x1070.44 ± 0.09 × 1074.7 ± 1.8 × 107
Dose of NK cells/kg infused0.96 ± 0.3 × 1070.34 ± 0.05 x1072.6 ± 1.5 × 107
Percentage NK cells39 ± 9%75 ± 6%54 ± 16%
Dose of T-cells/kg14 × 1046.2 × 1049.7 × 104
Percentage T cells0.7%1.3%0.3%
  • CD3, CD3 depletion; CD3CD56+, 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.