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Phase I trial evalu...
Phase I trial evaluating safety and efficacy of intratumorally administered inflammatory allogeneic dendritic cells (ilixadencel) in advanced gastrointestinal stromal tumors
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- Fröbom, Robin (author)
- Karolinska Institutet
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- Berglund, Erik (author)
- Karolinska Institutet
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- Berglund, David, 1984- (author)
- Uppsala universitet,Klinisk immunologi
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- Nilsson, Inga-Lena (author)
- Karolinska Institutet
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- Åhlén, Jan (author)
- Karolinska Inst, Dept Mol Med & Surg, Sect Endocrine & Sarcoma Surg, Stockholm, Sweden; Karolinska Univ Hosp, Dept Breast Canc, Div Canc Endocrine Tumors & Sarcoma, Stockholm, Sweden
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- von Sivers, Karin (author)
- Karolinska Univ Hosp, Dept Radiol, Stockholm, Sweden
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- Linder-Stragliotto, Christina (author)
- Karolinska Univ Hosp, Dept Breast Canc, Div Canc Endocrine Tumors & Sarcoma, Stockholm, Sweden
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- Suenaert, Peter (author)
- Immunicum AB, Stockholm, Sweden
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- Karlsson-Parra, Alex (author)
- Uppsala universitet,Klinisk immunologi,Immunicum AB, Stockholm, Sweden
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- Bränström, Robert (author)
- Karolinska Institutet
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(creator_code:org_t)
- 2020-06-13
- 2020
- English.
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In: Cancer Immunology and Immunotherapy. - : Springer Science and Business Media LLC. - 0340-7004 .- 1432-0851. ; 69:11, s. 2393-2401
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Abstract
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- BackgroundThe majority of patients with advanced gastrointestinal stromal tumor (GIST) develop resistance to imatinib, and subsequent treatments have limited efficacy. Ilixadencel (allogeneic inflammatory dendritic cells) is a cell-based immune primer injected intratumorally that previously has been clinically investigated in metastatic renal cell carcinoma and hepatocellular carcinoma.MethodsThe trial was a single arm phase I trial assessing safety and efficacy of ilixadencel in subjects with progressing advanced/metastatic GIST despite ongoing treatment with second or later lines of tyrosine kinase inhibitors (TKI). Three patients were progressing while on sunitinib (second line), one on regorafenib (third line), and two on pazopanib (fourth line). TKI treatment was maintained throughout, while two intratumoral injections of ilixadencel (10 × 106 viable and HLA-DR expressing cells per dose) were administered.ResultsNo severe adverse events were found to be related to ilixadencel administration. Four patients showed continued tumor progression at 3 months per RECIST 1.1 and Choi criteria. One patient (on third line regorafenib) had stable disease for 9 months and another patient (on second line sunitinib) had stable disease at end of study (12 months) as per RECIST 1.1. These two patients developed a partial response as per Choi criteria with a duration of 3 and 6 months, respectively. The median progression-free survival (PFS) was 4.0 months.ConclusionIlixadencel treatment presented an acceptable safety profile among advanced GIST patients who developed resistance to TKI. Encouraging radiological tumor responses were detected in 33% of treated patients, supporting further investigation.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- Gastrointestinal stromal tumor
- Immunotherapy
- Cell therapy
- Ilixadencel
- Tyrosine kinase inhibitor
- Dendritic cells
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Fröbom, Robin
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Berglund, Erik
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Berglund, David, ...
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Nilsson, Inga-Le ...
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Åhlén, Jan
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von Sivers, Kari ...
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Linder-Stragliot ...
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Suenaert, Peter
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Karlsson-Parra, ...
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Bränström, Rober ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
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Cancer Immunolog ...
- By the university
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Uppsala University
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Karolinska Institutet