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Table 3 Summary of samalizumab PK parameters

From: Phase I study of samalizumab in chronic lymphocytic leukemia and multiple myeloma: blockade of the immune checkpoint CD200

Dose

 

No. of patients

Tmax

(h)

Cmax

(μg/mL)

AUC∞

(μg·h/mL)

T1/2

(h)

CL

(mL/h)

Vz

(mL)

100 mg/m2

 

5

2.21 ± 3.25

38.9 ± 4.75

2792 ± 2227

85.1 ± 60.9

101 ± 67.5

8246 ± 1499

200 mg/m2

 

3

1.23 ± 0.09

90.2 ± 10.6

11,957 ± 6599

107 ± 45.2

36.3 ± 14.9

4943 ± 469

300 mg/m2

 

3

4.71 ± 4.65

109 ± 42.7

36,636 ± 11,540

371 ± 48.9

16.9 ± 4.15

9186 ± 3215

400 mg/m2

 

3

8.93 ± 11.1

135 ± 37.8

37,679 ± 7219

245 ± 33.9

21.3 ± 4.61

7391 ± 897

500 mg/m2

 

7

3.87 ± 1.85

211 ± 44.9

62,898 ± 24,222

365 ± 172

19.5 ± 10.4

8490 ± 1715

600 mg/m2

 

1

3.08

288

134,629

538

7.58

5880

  1. Values are presented as Mean ± SD. The samalizumab serum concentration assay had a lower limit of quantification of 3.70 μg/mL and the standard curve ranged from 3.7 to 100 μg/mL Assay precision was 1 to 18% and accuracy was 93.2 to 127.8% (Mean % of recovery)