Table 1 Demographics, baseline characteristics, underlying disease and HCT history.
PLX-R18, 1 M cells/kg (Cohort 1), N = 3 | PLX-R18, 2 M cells/kg (Cohort 2), N = 6 | PLX-R18, 4 M cells/kg (Cohort 3), N = 12 | Overall, N = 21 | P-value | |
|---|---|---|---|---|---|
Demographics | |||||
Age, years, mean (SD) | 49.0 (5.6) | 57.0 (3.8) | 57.0 (15.1) | 55.9 (11.9) | 0.58 |
Male, n (%) | 2 (66.7) | 2 (33.3) | 8 (66.7) | 12 (57.1) | 0.47 |
Caucasian. N (%) | 3 (100.0) | 5 (83.3) | 12 (100.0) | 20 (95.2) | 0.43 |
BMI, kg/m2, mean (SD) | 33.5 (7.5) | 26.0 (5.1) | 29.6 (6.7) | 29.1 (6.6) | 0.26 |
Blood count at baseline | |||||
Platelets, cells x 103/μL, median (min, max) | 24 (4.0, 24.5) | 21.8 (12.0, 46.0) | 36.3 (11.0, 83.25) | 30.5 (4.0, 83.25) | 0.06 |
platelets < 10 × 103/μL, n(%) | 1 (33.3) | 0 (0.0) | 0 (0.0) | 1 (4.8) | 0.14 |
platelets < 20 × 103/μL, n(%) | 1 (33.3) | 2 (33.3) | 2 (16.7) | 5 (23.8) | 0.64 |
Hemoglobin, g/dL, median (min, max) | 8.7 (8.5, 8.9) | 8.3 (6.5, 11.4) | 9.1 (6.3, 11.8) | 8.8 (6.3, 11.8) | 0.61 |
ANC, cells x 103/μL, median (min, max) | 2.1 (0.9, 3.2) | 1.2 (0.8, 1.6) | 1.2 (0.2, 1.9) | 1.3 (0.2, 3.2) | 0.09 |
ANC < 0.5 × 103/μL, n(%) | 0 (0.0) | 0 (0.0) | 3 (25.0) | 3 (14.3) | 0.70 |
ANC < 1 × 103/μL, n(%) | 1 (33.3) | 1 (16.7) | 5 (41.7) | 7 (33.3) | 0.81 |
Lymphocytes, cells x 103/μL, median (min, max) | 0.4 (0.3, 1.4) | 0.5 (0.1, 1.4) | 0.7 (0.3, 2.3) | 0.7 (0.1, 2.3) | 0.76 |
Disease history | |||||
Primary Diagnosis | |||||
Acute lymphoblastic leukemia (ALL), n(%) | 1 (33.3) | 3 (50.0) | 3 (25.0) | 7 (33.3) | |
Acute myelogenous leukemia (AML), n(%) | 1 (33.3) | 0 (0.0) | 2 (16.7) | 3 (14.3) | |
Multiple myeloma, n(%) | 0 (0.0) | 0 (0.0) | 2 (16.7) | 2 (9.5) | |
Myelodysplastic syndrome (MDS), n(%) | 0 (0.0) | 1 (16.7) | 1 (8.3) | 2 (9.5) | |
Non-Hodgkin lymphoma (NHL), n(%) | 1 (33.3) | 0 (0.0) | 1 (8.3) | 2 (9.5) | |
Other (malignant), n(%) | 0 (0.0) | 2 (33.3) | 3 (25.0) | 5 (23.8) | 0.81 |
HCT type, Allogeneic, n(%) | 2 (66.7) | 6 (100.0) | 11 (91.7) | 19 (90.5) | 0.34 |
HCT cell source | |||||
Bone marrow, n(%) | 1 (33.3) | 1 (16.7) | 4 (33.3) | 6 (28.6) | |
Peripheral blood, n(%) | 1 (33.3) | 5 (83.3) | 7 (58.3) | 13 (61.9) | |
Umbilical cord, n(%) | 1 (33.3) | 0 (0.0) | 1 (8.3) | 2 (9.5) | 0.51 |
Conditioning Regimen, Myeloablative n (%) | 3 (100.0) | 3 (50.0) | 8 (66.7) | 14 (66.7) | 0.86 |
Time from HCT, days, median (min, max) | 450 (872, 224) | 188 (540, 160) | 273 (792, 118) | 236 (872, 118) | 0.28 |
GVHD at screening, n (%) | 0 (0.0) | 1 (16.7) | 5 (41.7) | 6 (28.6) | 1.00 |
Acute, n | 0 | 0 | 1 | 1 | |
Chronic, n | 0 | 1 | 4 | 5 | |
Previous HCT, n(%) | 0 (0.0) | 2 (33.3) | 3 (25.0) | 5 (23.8) | 0.81 |
Transfusion dependence and history | |||||
Transfusion dependence, as defined by Investigator, n(%) | 3 (100.0) | 4 (66.7) | 6 (50.0) | 13 (61.9) | 0.34 |
Number of PLT transfusions per month at baseline, mean (SD)* | 4.9 (2.1) | 2.8 (2.4) | 6.8 (10.3) | 5.1 (7.1) | 0.66 |
Number of RBC transfusions per month at baseline, mean (SD)* | 3.1 (0.8) | 2.6 (1.1) | 3.1 (2.5) | 2.9 (1.8) | 0.91 |
