{"id":"her2-specific-t-cells","_chembl":null,"modality":"Biologic","_dailymed":null,"mechanism":{"target":"HER2 (human epidermal growth factor receptor 2)","explanation":"These T cells are genetically modified or selected to express receptors that recognize the HER2 protein, which is overexpressed in certain cancers. Upon infusion into patients, the HER2-specific T cells seek out and bind to HER2-positive cancer cells, triggering an immune response that leads to tumor cell destruction.","oneSentence":"Engineered T cells that specifically recognize and destroy cancer cells expressing the HER2 protein on their surface."},"_scrapedAt":"2026-03-28T04:12:20.779Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_claudeStub":{"ts":1779122990,"model":"claude-sonnet-4-5-20250929"},"competitors":[{"name":"trastuzumab","brand":"Herceptin","company":"Genentech/Roche","rationale":"Monoclonal antibody targeting HER2-positive cancers"},{"name":"pertuzumab","brand":"Perjeta","company":"Genentech/Roche","rationale":"HER2-targeted monoclonal antibody for HER2-positive malignancies"},{"name":"ado-trastuzumab emtansine","brand":"Kadcyla","company":"Genentech/Roche","rationale":"HER2-targeted antibody-drug conjugate"}],"description":"HER2-specific T cells are an investigational adoptive cell therapy developed by Baylor College of Medicine. These genetically modified immune cells are designed to recognize and attack cancer cells expressing the HER2 protein, offering a potential treatment approach for HER2-positive malignancies.","indications":{"approved":[{"status":"investigational","condition":"HER2-positive cancers","patientPopulation":"Adult patients with HER2-overexpressing tumors"}]},"trialDetails":[{"nctId":"NCT04903080","phase":"PHASE1","title":"HER2-specific Chimeric Antigen Receptor (CAR) T Cells for Children With Ependymoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Children's Oncology Group","startDate":"2022-07-27","conditions":"Ependymoma","enrollment":50},{"nctId":"NCT04144023","phase":"PHASE1","title":"A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ","status":"RECRUITING","sponsor":"Mayo Clinic","startDate":"2019-06-27","conditions":"Breast Ductal Carcinoma In Situ","enrollment":43},{"nctId":"NCT06251544","phase":"PHASE1","title":"TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Metastatic Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Baylor College of Medicine","startDate":"2026-06","conditions":"Breast Cancer, Tumor, Breast, Breast Tumor","enrollment":27},{"nctId":"NCT03740256","phase":"PHASE1","title":"Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR VST, Advanced HER2 Positive Solid Tumors","status":"RECRUITING","sponsor":"Baylor College of Medicine","startDate":"2020-12-14","conditions":"Bladder Cancer, Head and Neck Squamous Cell Carcinoma, Cancer of the Salivary Gland","enrollment":45},{"nctId":"NCT04884282","phase":"PHASE2","title":"Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Fondazione Ricerca Traslazionale","startDate":"2021-10-12","conditions":"Metastatic Non Small Cell Lung Cancer","enrollment":105},{"nctId":"NCT03389230","phase":"PHASE1","title":"Memory-Enriched T Cells in Treating Patients With Recurrent or Refractory Grade III-IV Glioma","status":"ACTIVE_NOT_RECRUITING","sponsor":"City of Hope Medical Center","startDate":"2018-08-14","conditions":"Glioblastoma, Malignant Glioma, Recurrent Glioma","enrollment":29},{"nctId":"NCT07192432","phase":"PHASE1, PHASE2","title":"Gene Therapy for HER-Positive Cancer (SENTRY-HER2)","status":"RECRUITING","sponsor":"Vironexis Biotherapeutics Inc.","startDate":"2025-11-18","conditions":"HER2 Expressing Solid Tumors","enrollment":27},{"nctId":"NCT00902044","phase":"PHASE1","title":"Her2 Chimeric Antigen Receptor Expressing T Cells in Advanced Sarcoma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Baylor College of Medicine","startDate":"2010-02-11","conditions":"Sarcoma","enrollment":36},{"nctId":"NCT05378464","phase":"PHASE1","title":"Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer","status":"RECRUITING","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2022-05-31","conditions":"HER2-positive Breast Cancer","enrollment":28},{"nctId":"NCT03500991","phase":"PHASE1","title":"HER2-specific CAR T Cell Locoregional Immunotherapy for HER2-positive Recurrent/Refractory Pediatric CNS Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Seattle Children's Hospital","startDate":"2018-07-26","conditions":"Central Nervous System Tumor, Pediatric, Glioma, Ependymoma","enrollment":10},{"nctId":"NCT02442297","phase":"PHASE1","title":"T Cells Expressing HER2-specific Chimeric Antigen Receptors(CAR) for Patients With HER2-Positive CNS Tumors","status":"ACTIVE_NOT_RECRUITING","sponsor":"Baylor College of Medicine","startDate":"2016-04-01","conditions":"Brain Tumor, Recurrent, Brain Tumor, Refractory","enrollment":10},{"nctId":"NCT07066982","phase":"PHASE1, PHASE2","title":"Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas","status":"RECRUITING","sponsor":"Essen Biotech","startDate":"2025-05-29","conditions":"Sarcoma, Sarcoma, Kaposi, Sarcoma, Ewing","enrollment":60},{"nctId":"NCT03632941","phase":"PHASE2","title":"A Study to Evaluate Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"Herbert Lyerly","startDate":"2019-03-01","conditions":"Breast Cancer, HER2+ Breast Cancer","enrollment":8},{"nctId":"NCT04684459","phase":"EARLY_PHASE1","title":"Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors","status":"RECRUITING","sponsor":"Sichuan University","startDate":"2021-03-12","conditions":"Peritoneal Carcinoma Metastatic, Pleural Effusion, Malignant, HER2 Positive Malignancies","enrollment":18},{"nctId":"NCT00194714","phase":"PHASE1, PHASE2","title":"Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab","status":"COMPLETED","sponsor":"University of Washington","startDate":"2016-05","conditions":"HER2/Neu Positive, HLA-A2 Positive Cells Present, Stage IV Breast Cancer","enrollment":22},{"nctId":"NCT06328387","phase":"PHASE1, PHASE2","title":"HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer","status":"RECRUITING","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","startDate":"2024-01-29","conditions":"Advanced Breast Cancer, Metastatic Breast Cancer","enrollment":120},{"nctId":"NCT00499083","phase":"PHASE2","title":"Paclitaxel, Cyclophosphamide & Doxorubicin, Autologous Dendritic Cells & Surgery in Stage II/III Breast Cancer (Women)","status":"COMPLETED","sponsor":"University of Nebraska","startDate":"2006-05-01","conditions":"Breast Cancer","enrollment":17},{"nctId":"NCT04020575","phase":"PHASE1","title":"Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)","status":"RECRUITING","sponsor":"Minerva Biotechnologies Corporation","startDate":"2020-01-15","conditions":"Metastatic Breast Cancer","enrollment":69},{"nctId":"NCT03423992","phase":"PHASE1","title":"Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas","status":"UNKNOWN","sponsor":"Xuanwu Hospital, Beijing","startDate":"2018-03-02","conditions":"Glioma, Malignant Glioma of Brain, Recurrence Tumor","enrollment":100},{"nctId":"NCT04433221","phase":"PHASE1, PHASE2","title":"Combination Immunotherapy Targeting Sarcomas","status":"UNKNOWN","sponsor":"Shenzhen Geno-Immune Medical Institute","startDate":"2020-07-01","conditions":"Sarcoma, Osteoid Sarcoma, Ewing Sarcoma","enrollment":20},{"nctId":"NCT01109095","phase":"PHASE1","title":"CMV-specific Cytotoxic T Lymphocytes Expressing CAR Targeting HER2 in Patients With GBM","status":"COMPLETED","sponsor":"Baylor College of Medicine","startDate":"2010-10","conditions":"Glioblastoma Multiforme 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in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer","status":"TERMINATED","sponsor":"University of Washington","startDate":"2012-12","conditions":"HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer","enrollment":3},{"nctId":"NCT00363012","phase":"NA","title":"Immune Response in Patients Who Have Undergone Vaccine Therapy for Stage III or Stage IV Breast Cancer That Overexpresses HER2","status":"COMPLETED","sponsor":"University of Washington","startDate":"2006-04","conditions":"Breast Cancer","enrollment":56},{"nctId":"NCT00228358","phase":"PHASE1","title":"Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patient's Own T Cells in the Laboratory in Treating Patients With HER-2/Neu Overexpressing Metastatic Breast Cancer, Ovarian Cancer, or Non-Small Cell Lung Cancer Previously Treated With HER-2/Neu Vaccine","status":"COMPLETED","sponsor":"University of Washington","startDate":"2003-06","conditions":"HER2-positive Breast 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