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Ref Type Journal Article
PMID (28710747)
Authors Feng K, Liu Y, Guo Y, Qiu J, Wu Z, Dai H, Yang Q, Wang Y, Han W
Title Phase I study of chimeric antigen receptor modified T cells in treating HER2-positive advanced biliary tract cancers and pancreatic cancers.
Journal Protein & cell
Vol 9
Issue 10
Date 2018 10
URL
Abstract Text 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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Molecular Profile Treatment Approach
ERBB2 over exp HER2 (ERBB2) Immune Cell Therapy
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 over exp pancreatic carcinoma predicted - sensitive HER2 CAR-T cells Phase I Actionable In a Phase I trial, treatment with ERBB2 (HER2)-specific CAR-T cells demonstrated safety and preliminary activity in patients with biliary tract or pancreatic carcinoma with ERBB2 (HER2) over expression, resulting in partial response in one of 11 patients and stable disease in 5, and a median progression free survival of 4.8 months (PMID: 28710747; NCT01935843). 28710747
ERBB2 over exp cholangiocarcinoma predicted - sensitive HER2 CAR-T cells Phase I Actionable In a Phase I trial, a patient with perihilar cholangiocarcinoma over expressing ERBB2 achieved a partial response and progression-free survival for 4.5 months following treatment with ERBB2 (HER2)-specific CAR-T cells (PMID: 28710747, NCT01935843). 28710747
ERBB2 over exp biliary tract cancer predicted - sensitive HER2 CAR-T cells Phase I Actionable In a Phase I trial, treatment with ERBB2 (HER2)-specific CAR-T cells demonstrated safety and preliminary activity in patients with biliary tract or pancreatic carcinoma with ERBB2 (HER2) over expression, resulting in partial response in one of 11 patients and stable disease in 5, and a median progression free survival of 4.8 months (PMID: 28710747; NCT01935843). 28710747