Table 2.
Clinical results that have administered NK cells in combination with antibodies within the last 5 years.
| Study Phase. NCT Number. Reference | Monoclonal Antibody | Source of NK and Method of Expansion | Condition (Disease) and Number of Patients | Clinical Outcome |
|---|---|---|---|---|
| Phase I/II NCT02030561 Lee et al. [32] |
Trastuzumab (anti-HER2) | Autologous PBNK + K562-mb15-41BBL + IL-2 for 10 days | HER2+ refractory cancer. Phase I (n = 9)/II (n = 20) | Phase I: well tolerated. 66.6% SD (>6 months). 11% PR. |
| Phase I/II NCT02845856 [33] | Cetuximab (anti-EGFR) | Allogeneic PB-NK + K562-mb15-41BBL | Non-small Cell Lung Cancer (n = 54) |
OS 9.5 months and PFS 6 month vs. 7.5 and 4.5 given Cetuximab alone |
| Phase I/II NCT02843204 Lin, M. et al. [44] |
Pembrolizumab (anti-PD1) | Allogenic PB-NK + 10 IU/mL IL-2 | Advanced non-small cell lung cancer (n = 109) | OS 15.5 months and PFS 6.5 months vs. 13.3 and 4.3 given Pembrolizumab alone |
| Phase II NCT03958097 Hospital of Jilin University |
Sintilimab (anti-PD1) | Autologous PB-NK | Non-small cell lung cancer | NRP |
| Phase I NCT03841110 |
Nivolumab (anti-PD1), Pembrolizumab (anti-PD1), Atezolizumab (anti-PDL1) | iPSC-derived NK cell (FT500) | Advanced solid tumors and lymphomas (n = 76 estimated) | NRP |
| Phase I NCT03815084 |
Pembrolizumab (anti-PD1) | DC and NK cells | Solid tumors | NRP |
| Phase I/IIa NCT03937895 |
Pembrolizumab (anti-PD1) | Allogeneic NK Cell (“SMT-NK”) | Advanced Biliary Tract Cancer | NRP |
| Phase II NCT03853317 |
Avelumab (anti-PDL1) | Off-the-shelf CD16-targeted NK cells with intracellular IL2 (haNK) and IL-15 Superagonist (N-803) | Merkel Cell Carcinoma | NRP |
SD: stable disease; PR: partial response; OS: overall survival; PFS: progression free survival; ORR: overall response rate; NRP: no results posted; DC: dendritic cell; PB-NK: peripheral blood NK cells.