Table 4.
Clinical trials and outcomes after haplo-HSCT with NK cells.
| Author | Diagnosis/ Patient Number |
Donor | Conditioning | GvHD Prophylaxis |
Cell Source and Dose | Survival | CI of aGvHD | CI of cGvHD |
|---|---|---|---|---|---|---|---|---|
| Choi, I. et al. Biol. Blood Marrow Transpl. 2014 [105] |
Adults with hematological malignancies, mostly AML (n = 41) |
haplo | RIC | CSA (n = 13); MTX + CSA (n = 28) |
Donor-derived NK cells Infusion 2 and 3 weeks after transplant Escalating doses (median dose of 2.0 × 108/kg) |
31.5 months DFS: 31% OS: 35% (AML) |
22% | 24% |
| Ciurea, S.O. et al. Blood 2017 [114] | Adults with high-risk myeloid malignancies (n = 13) |
haplo | RIC | CY (50 mg/kg per day on days 13 and 14) + tacrolimus from day 15 and for 6 months +MMF from day 15 and for 3 months |
Membrane-bound IL-21 expanded donor NK cells Doses ranging from 1 × 105/kg to 3 × 108 kg) |
1 year OS: 92% 1 year DFS: 85% |
Grade I–II: 54% Grade III–IV: 0 |
0 |
| Berrien-Elliot, M.M. et al. Sci. Transl. Med. 2022 [110] | Adult patients with high-risk AML (n = 15) |
haplo | RIC | tacrolimus and MMF starting on day +5 (until days +180 and +35, respectively) |
Donor-derived memory-like NK cells. Doses ranging from 0.5 × 106 to 10 × 106 cells/kg IL 15 agonist administered subcutaneously on day +7 and over 3 weeks. |
1y OS: 29% | Grade I: 26% Grade II: 40% |
All grade: 13% |
| Shapiro, R.M. et al. J. Clin. Investig. 2022 [119] |
Relapsed myeloid malignancies after haplo HCT (n = 6) |
haplo | RIC | ATG + tacrolimus + MTX (n = 21), ATG + tacrolimus (n = 5), ATG + MTX (n = 2), ATG (n = 5) |
Donor-derived memory like NK cells Dose ranging from 5 to 10 × 106 cells/kg + IL2 (7 doses) |
All grade: 0 | All grade: 0 |
CSA: cyclosporine; MTX: methotrexate; AML: acute myeloid leukemia; RIC: reduced-intensity conditioning; CY: cyclophosphamide; MMF: mycophenolate mofetile; ATG: anti-thymocyte globulin.