Table 1. The list of clinical trials registered to United States National Library of Medicine (www.clinicaltrials.gov) for treatment of HCC patients using NK cells.
| Study title | Phase | Intervention/treatment | Patient | Status | Results | Identifier |
|---|---|---|---|---|---|---|
| Safety study of NK cells from sibship to treat the recurrence of HCC after liver transplantation | 1 | Bio.: low dose NK cells × 4 times; normal dose NK cells × 4 times; normal dose NK cells × 8 times | 18 | U | No results posted | NCT02399735 |
| Safety and efficacy of allogeneic NK cells therapy in patients with advanced HCC | 1; 2 | Bio.: allogeneic NK cells therapy | 200 | R | No results posted | NCT04162158 |
| By using adoptive transfer of autologous NK cells to prevent recurrence of HCC after curative therapy | 2 | Bio.: NK cells; Other: curative therapy | 140 | U | No results posted | NCT02725996 |
| A novel immunotherapy for liver transplant patients with HCC: anti-tumor effect of IL2-activated donor liver NK cell | 1 | Bio.: liver NK cell inoculation | 10 | C | No study related adverse effects observed | NCT01147380 |
| A single center, open-label, phase II clinical trial to evaluate the efficacy and safety of MG4101 (ex vivo expanded allogeneic NK cell) in HCC after curative resection | 2 | Bio.: MG4101 | 5 | C | No results posted | NCT02008929 |
| Multi-center, open, phase 2a clinical trial to evaluate the efficacy and safety of MG4101 in HCC after TACE | 2 | Bio.: MG4101 | 78 | C | No results posted | NCT02854839 |
| A randomized controlled study of cytokine-induced killer cell (CIK) treatment in patients with HCC who underwent radical resection. | 3 | Bio.: CIK cell treatment | 200 | C | Median TTR: 13.6 (CIK); 7.8 (control) | NCT00769106 |
| No significant DFS or OS difference | ||||||
| Stage I/II adverse events | ||||||
| A phase I study to evaluate the safety and efficacy of autologous immune killer cells (IKC) in patients with late-stage HCC or lung cancer | 1 | Bio.: IKC | 20 | C | No results posted | NCT03515252 |
| A Phase II/III clinical trial with ex vivo expanded autologous immune killer cells to treat liver cancer patients as an adjunct therapy | 2; 3 | Bio.: IKC; Proc.: TACE | 60 | R | No results posted | NCT03592706 |
| A randomized controlled study of CIK cell treatment in patients with HCC who underwent radical resection | 3 | Bio.: CIK cells | 200 | C | No results posted | NCT01749865 |
| Long-term, non-interventional, observational study following treatment with fate therapeutics FT500 cellular immunotherapy | NA | Gen.: allogeneic NK cell | 76 | R | No results posted | NCT04106167 |
| Evaluation of CIK cells as therapy or adjuvant treatment for patients with advanced HCC | 3 | Bio.: CIK; Proc.: TACE | 20 | U | No results posted | NCT02568748 |
| Study evaluating the efficacy and safety of chimeric antigen receptor (CAR) modified pNK cells in MUC1 positive advanced refractory or relapsed solid tumor | 1 & 2 | Bio.: anti-MUC1 CAR-pNK cells | 10 | U | No results posted | NCT02839954 |
| FT500 as monotherapy and in combination with immune checkpoint inhibitors in subjects with advanced solid tumors (phase I) | 1 | Drug: FT500, Nivolumab, Pembrolizumab, Atezolizumab, Cyclophosphamide, Fludarabine | 76 | R | No results posted | NCT03841110 |
| Phase I/II study of NK T cell infusion in patients with advanced solid tumor | 1 & 2 | Bio.: NK T cell | 120 | U | No results posted | NCT02562963 |
| FATE-NK100 as monotherapy and in combination with monoclonal antibody in subjects with advanced solid tumors | 1 | Drug: FATE-NK100, Cetuximab, Trastuzumab | 100 | A/NR | No results posted | NCT03319459 |
| A phase I open label, single site, safety and efficacy study of the effects of autologous NK and NK T cell immunotherapy on malignant disease | 1 | Bio.: autologous NK/NK-T cell immunotherapy | 24 | S | No results posted | NCT00909558 |
A, active; C, completed; NR, not recruiting; R, recruiting; S, suspended; U, unknown; HCC, hepatocellular carcinoma; NK, natural killer; TACE, transarterial chemoembolization; DFS, disease-free survival; OS, overall survival.