Table 1.
Clinical results in the last 5 years administrating natural killer (NK) cells.
| NCT Number. Phase. Investigator. Reference | Source of NK and Method of Expansion | Stage of Disease and Number of Patients | Clinical Outcome |
|---|---|---|---|
| NCT01181258. Phase II. Bachanova, V. et al. [21] | Allogeneic PB-NK + IL-2 (1000 IU/mL) | R/R NHL or CLL CD20+. 14 evaluable patients. | 4/14 OR at 2 months (28%). 2/24 CR for 9 months (14%) |
| NCT01898793. Phase I/II. Romee, R. et al. [25] | Haploidentical PB-NK + 12–16 h: IL-15, IL-12 and IL-18. 3 doses: 0.5, 1 and 106 NK/Kg |
R/R AML (n = 13, 9 evaluable). | Well tolerated, no GvHD. OR: 55% CR: 45% |
| NCT02271711. Phase I. Khatua, S. et al. [28] | Autologous PB-NK + K562-mbIL-21 | R/R brain tumor: medulloblastoma (n = 5) and ependymoma (n = 4) in pediatric patients | SD: 11.1% PD: 88.9% |
| NCT00526292. Phase II. Shaffer, B. C. et al. [30] | Haploidentical PB-NK. 6 doses of IL-2 in patients every other day. | AML (n = 6) and MDS (n = 2) | No GvHD PR: 37.5% CR: 25% Median OS = 12.9 months |
| EudraCT number 2011-003181-32. Bjorklund, A. T. et al. [29] | Allogeneic PBNK + IL-2 (1000 IU/mL) | R/R or high-risk MDS (n = 5), MDS-AML (n = 9) or de novo AML (n = 3). 16 evaluable. | OR: 37.5% and SD: 12.5% 5/16 underwent allo-SCT. Of these in 3/16, DFS > 3 years |
| NCT01212341. Phase I. Tae Min Kim [31] | Allogeneic PB-NK. 14 days of expansion with irradiated auto-PBMCs, OKT3 +IL-2 (500 IU/mL) every other day |
Lymphoma (n = 2) and solid tumor (n = 19). 17 evaluable | No GvHD, no severe toxicities. 47.1% SD, 52.9% PD, median PFS in SD patients of 4 months |
R/R: relapsed/refractory; OR: objective response; SD: stable disease; PR: partial response; PD: progressive disease; CR: complete response; GvHD: graft-versus-host disease; NE: not evaluable; MLFS: morphologic leukemia-free state; allo-SCT: allogeneic stem cell transplantation; OS: overall survival; PFS: progression free survival.