Phase I study of expanded natural killer cells in combination with cetuximab for recurrent/metastatic nasopharyngeal carcinoma
Background Nasopharyngeal carcinoma (NPC) cells express high levels of epidermal growth factor receptor (EGFR). Cetuximab is an anti-EGFR monoclonal antibody that promotes natural killer (NK) cell-mediated antibody-dependent cellular cytotoxicity (ADCC) via engagement of CD16. We studied safety and...
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Published in | Cancer Immunology, Immunotherapy Vol. 71; no. 9; pp. 2277 - 2286 |
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Main Authors | , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Berlin/Heidelberg
Springer Berlin Heidelberg
01.09.2022
Springer Nature B.V |
Subjects | |
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Abstract | Background
Nasopharyngeal carcinoma (NPC) cells express high levels of epidermal growth factor receptor (EGFR). Cetuximab is an anti-EGFR monoclonal antibody that promotes natural killer (NK) cell-mediated antibody-dependent cellular cytotoxicity (ADCC) via engagement of CD16. We studied safety and efficacy of combining cetuximab with autologous expanded NK cells in patients with recurrent and/or metastatic NPC who had failed at least two prior lines of chemotherapy.
Methods
Seven subjects (six patients) received cetuximab every 3 weeks (six doses maximum) in the pre-trial phase. Autologous NK cells, expanded by co-culture with irradiated K562-mb15-41BBL cells, were then infused on the day after administration of cetuximab. Primary and secondary objectives were to determine safety of this combination therapy and to assess tumor responses, respectively.
Results
Median NK cell expansion from peripheral blood mononucleated cells after 10 days of culture with K562-mb15-41BBL was 274-fold (range, 36–534,
n
= 10), and the median expression of CD16 was 98.4% (range, 67.8–99.7%). Skin rash, the commonest side effect of cetuximab in the pre-trial phase, was not exacerbated by NK cell infusion. No intolerable side effects were observed. Stable disease was observed in four subjects and progressive disease in three subjects. Three patients who received NK cells twice had time to disease progression of 12, 13, and 19 months.
Conclusion
NK cells with high ADCC potential can be expanded from patients with heavily pre-treated NPC. The safety profile and encouraging clinical responses observed after combining these cells with cetuximab warrant further studies of this approach. (clinicalTrials.gov NCT02507154, 23/07/2015).
Precis
Engaging NK cell-mediated ADCC using cetuximab plus autologous NK cells in EGFR-positive NPC was well tolerated among heavily pre-treated recurrent NPC. Promising results were observed with 3 out of 7 subjects demonstrating durable stable disease. |
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AbstractList | BACKGROUNDNasopharyngeal carcinoma (NPC) cells express high levels of epidermal growth factor receptor (EGFR). Cetuximab is an anti-EGFR monoclonal antibody that promotes natural killer (NK) cell-mediated antibody-dependent cellular cytotoxicity (ADCC) via engagement of CD16. We studied safety and efficacy of combining cetuximab with autologous expanded NK cells in patients with recurrent and/or metastatic NPC who had failed at least two prior lines of chemotherapy.METHODSSeven subjects (six patients) received cetuximab every 3 weeks (six doses maximum) in the pre-trial phase. Autologous NK cells, expanded by co-culture with irradiated K562-mb15-41BBL cells, were then infused on the day after administration of cetuximab. Primary and secondary objectives were to determine safety of this combination therapy and to assess tumor responses, respectively.RESULTSMedian NK cell expansion from peripheral blood mononucleated cells after 10 days of culture with K562-mb15-41BBL was 274-fold (range, 36-534, n = 10), and the median expression of CD16 was 98.4% (range, 67.8-99.7%). Skin rash, the commonest side effect of cetuximab in the pre-trial phase, was not exacerbated by NK cell infusion. No intolerable side effects were observed. Stable disease was observed in four subjects and progressive disease in three subjects. Three patients who received NK cells twice had time to disease progression of 12, 13, and 19 months.CONCLUSIONNK cells with high ADCC potential can be expanded from patients with heavily pre-treated NPC. The safety profile and encouraging clinical responses observed after combining these cells with cetuximab warrant further studies of this approach. (clinicalTrials.gov NCT02507154, 23/07/2015).PRECISEngaging NK cell-mediated ADCC using cetuximab plus autologous NK cells in EGFR-positive NPC was well tolerated among heavily pre-treated recurrent NPC. Promising results were observed with 3 out of 7 subjects demonstrating durable stable disease. Nasopharyngeal carcinoma (NPC) cells express high levels of epidermal growth factor receptor (EGFR). Cetuximab is an anti-EGFR monoclonal antibody that promotes natural killer (NK) cell-mediated antibody-dependent cellular cytotoxicity (ADCC) via engagement of CD16. We studied safety and efficacy of combining cetuximab with autologous expanded NK cells in patients with recurrent and/or metastatic NPC who had failed at least two prior lines of chemotherapy. Seven subjects (six patients) received cetuximab every 3 weeks (six doses maximum) in the pre-trial phase. Autologous NK cells, expanded by co-culture with irradiated K562-mb15-41BBL cells, were then infused on the day after administration of cetuximab. Primary and secondary objectives were to determine safety of this combination therapy and to assess tumor responses, respectively. Median NK cell expansion from peripheral blood mononucleated cells after 10 days of culture with K562-mb15-41BBL was 274-fold (range, 36-534, n = 10), and the median expression of CD16 was 98.4% (range, 67.8-99.7%). Skin rash, the commonest side effect of cetuximab in the pre-trial phase, was not exacerbated by NK cell infusion. No intolerable side effects were observed. Stable disease was observed in four subjects and progressive disease in three subjects. Three patients who received NK cells twice had time to disease progression of 12, 13, and 19 months. NK cells with high ADCC potential can be expanded from patients with heavily pre-treated NPC. The safety profile and encouraging clinical responses observed after combining these cells with cetuximab warrant further studies of this approach. (clinicalTrials.gov NCT02507154, 23/07/2015). Engaging NK cell-mediated ADCC using cetuximab plus autologous NK cells in EGFR-positive NPC was well tolerated among heavily pre-treated recurrent NPC. Promising results were observed with 3 out of 7 subjects demonstrating durable stable disease. Background Nasopharyngeal carcinoma (NPC) cells express high levels of epidermal growth factor receptor (EGFR). Cetuximab is an anti-EGFR monoclonal antibody that promotes natural killer (NK) cell-mediated antibody-dependent cellular cytotoxicity (ADCC) via engagement of CD16. We studied safety and efficacy of combining cetuximab with autologous expanded NK cells in patients with recurrent and/or metastatic NPC who had failed at least two prior lines of chemotherapy. Methods Seven subjects (six patients) received cetuximab every 3 weeks (six doses maximum) in the pre-trial phase. Autologous NK cells, expanded by co-culture with irradiated K562-mb15-41BBL cells, were then infused on the day after administration of cetuximab. Primary and secondary objectives were to determine safety of this combination therapy and to assess tumor responses, respectively. Results Median NK cell expansion from peripheral blood mononucleated cells after 10 days of culture with K562-mb15-41BBL was 274-fold (range, 36–534, n = 10), and the median expression of CD16 was 98.4% (range, 67.8–99.7%). Skin rash, the commonest side effect of cetuximab in the pre-trial phase, was not exacerbated by NK cell infusion. No intolerable side effects were observed. Stable disease was observed in four subjects and progressive disease in three subjects. Three patients who received NK cells twice had time to disease progression of 12, 13, and 19 months. Conclusion NK cells with high ADCC potential can be expanded from patients with heavily pre-treated NPC. The safety profile and encouraging clinical responses observed after combining these cells with cetuximab warrant further studies of this approach. (clinicalTrials.gov NCT02507154, 23/07/2015). Precis Engaging NK cell-mediated ADCC using cetuximab plus autologous NK cells in EGFR-positive NPC was well tolerated among heavily pre-treated recurrent NPC. Promising results were observed with 3 out of 7 subjects demonstrating durable stable disease. |
Author | Liou, Anthony Shimasaki, Noriko Loh, Kwok Seng Poon, Michelle Koh, Liang Piu Tan, Lip Kun Petersson, Bengt Fredrik Lim, Chwee Ming Campana, Dario Ting, Eric Goh, Boon Cher |
Author_xml | – sequence: 1 givenname: Chwee Ming orcidid: 0000-0001-9528-4365 surname: Lim fullname: Lim, Chwee Ming email: lim.chwee.ming@singhealth.com.sg organization: Department of Otorhinolaryngology—Head and Neck Surgery, Singapore General Hospital, Duke–NUS Medical School – sequence: 2 givenname: Anthony surname: Liou fullname: Liou, Anthony organization: Department of Otorhinolaryngology—Head and Neck Surgery, Singapore General Hospital – sequence: 3 givenname: Michelle surname: Poon fullname: Poon, Michelle organization: Department of Hematology and Oncology, National University Health System, National University Cancer Institute, National University Health System – sequence: 4 givenname: Liang Piu surname: Koh fullname: Koh, Liang Piu organization: Department of Hematology and Oncology, National University Health System, National University Cancer Institute, National University Health System – sequence: 5 givenname: Lip Kun surname: Tan fullname: Tan, Lip Kun organization: Department of Hematology and Oncology, National University Health System, National University Cancer Institute, National University Health System – sequence: 6 givenname: Kwok Seng surname: Loh fullname: Loh, Kwok Seng organization: National University Cancer Institute, National University Health System, Department of Otolaryngology—Head and Neck Surgery, National University Health System – sequence: 7 givenname: Bengt Fredrik surname: Petersson fullname: Petersson, Bengt Fredrik organization: Department of Pathology, National University of Singapore – sequence: 8 givenname: Eric surname: Ting fullname: Ting, Eric organization: Department of Diagnostic Radiology, National University Health System – sequence: 9 givenname: Dario surname: Campana fullname: Campana, Dario organization: Department of Pediatrics, National University of Singapore – sequence: 10 givenname: Boon Cher surname: Goh fullname: Goh, Boon Cher organization: Department of Hematology and Oncology, National University Health System, National University Cancer Institute, National University Health System – sequence: 11 givenname: Noriko surname: Shimasaki fullname: Shimasaki, Noriko organization: Department of Pediatrics, National University of Singapore |
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Keywords | Nasopharyngeal carcinoma Clinical trial NK cell therapy Cetuximab EGFR |
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Snippet | Background
Nasopharyngeal carcinoma (NPC) cells express high levels of epidermal growth factor receptor (EGFR). Cetuximab is an anti-EGFR monoclonal antibody... Nasopharyngeal carcinoma (NPC) cells express high levels of epidermal growth factor receptor (EGFR). Cetuximab is an anti-EGFR monoclonal antibody that... BackgroundNasopharyngeal carcinoma (NPC) cells express high levels of epidermal growth factor receptor (EGFR). Cetuximab is an anti-EGFR monoclonal antibody... BACKGROUNDNasopharyngeal carcinoma (NPC) cells express high levels of epidermal growth factor receptor (EGFR). Cetuximab is an anti-EGFR monoclonal antibody... |
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SubjectTerms | Antibodies, Monoclonal, Humanized - pharmacology Antibody-Dependent Cell Cytotoxicity Cancer Research CD16 antigen Cell culture Cell Line, Tumor Cetuximab - pharmacology Cetuximab - therapeutic use Chemotherapy Clinical Trial Report Cytotoxicity Epidermal growth factor Epidermal growth factor receptors Humans Immunology Killer Cells, Natural Medicine Medicine & Public Health Metastases Metastasis Monoclonal antibodies Nasopharyngeal carcinoma Nasopharyngeal Carcinoma - drug therapy Nasopharyngeal Neoplasms - drug therapy Natural killer cells Neoplasm Recurrence, Local - drug therapy Neoplasm Recurrence, Local - metabolism Oncology Patients Peripheral blood Safety Side effects Targeted cancer therapy Throat cancer Tumors |
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Title | Phase I study of expanded natural killer cells in combination with cetuximab for recurrent/metastatic nasopharyngeal carcinoma |
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