The DOI matches its Crossref record; 31 of the 31 references it cites were found in a registry or an index.
Phase I study of chimeric antigen receptor modified T cells in treating HER2-positive advanced biliary tract cancers and pancreatic cancers
Open accessAbstract
This phase I clinical trial (NCT01935843) is to evaluate the safety, feasibility, and activity of chimeric antigen receptor-engineered T cell (CART) immunotherapy targeting human epidermal growth factor receptor 2 (HER2) in patients with advanced biliary tract cancers (BTCs) and pancreatic cancers (PCs). Eligible patients with HER2-positive (>50%) BTCs and PCs were enrolled in the trial. Well cultured CART-HER2 cells were infused following the conditioning treatment composed of nab-paclitaxel (100–200 mg/m2) and cyclophosphamide (15–35 mg/kg). CAR transgene copy number in the peripheral blood was serially measured to monitor the expansion and persistence of CART-HER2 cells in vivo. Eleven enrolled patients received 1 to 2-cycle CART-HER2 cell infusion (median CAR+ T cell 2.1 × 106/kg). The conditioning treatment resulted in mild-to-moderate fatigue, nausea/vomiting, myalgia/arthralgia, and lymphopenia. Except one grade-3 acute febrile syndrome and one abnormal elevation of transaminase (>9 ULN), adverse events related to the infusion of CART-HER2 cells were mild-to-moderate. Post-infusion toxicities included one case of reversible severe upper gastrointestinal hemorrhage which occurred in a patient with gastric antrum invaded by metastasis 11 days after the CART-HER2 cell infusion, and 2 cases of grade 1–2 delayed fever, accompanied by the release of C-reactive protein and interleukin-6. All patients were evaluable for assessment of clinical response, among which 1 obtained a 4.5-months partial response and 5 achieved stable disease. The median progression free survival was 4.8 months (range, 1.5–8.3 months). Finally, data from this study demonstrated the safety and feasibility of CART-HER2 immunotherapy, and showed encouraging signals of clinical activity.
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Metadata
- Authors
- Feng, K., Liu, Y., Guo, Y., Qiu, J., Wu, Z., Dai, H., Yang, Q., Wang, Y., & Han, W.
- Venue
- Protein & Cell
- Publisher
- Oxford University Press (OUP)
- Published
- 2017-07-14
- Volume
- 9
- Issue
- 10
- Pages
- 838-847
- ISSN
- 1674-800X (ISSN-L)
- 1674-8018
- OpenAlex
- W2734751581
- Cited by
- 326
- References
- 31
- FWCI
- 6.46
- Type
- journal article
- Language
- en
- Open access
- gold
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- Feng, K., Liu, Y., Guo, Y., Qiu, J., Wu, Z., Dai, H., Yang, Q., Wang, Y., & Han, W. (2018). Phase I study of chimeric antigen receptor modified T cells in treating HER2-positive advanced biliary tract cancers and pancreatic cancers. Protein & Cell. https://doi.org/10.1007/s13238-017-0440-4
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