Evaluation of Subtractive Immunopheresis for Treatment of Hormone-Refractive Advanced Breast Cancer

减法免疫去除术治疗激素折射晚期乳腺癌的评价

• 批准号: 10483880
• 负责人: Christian Shenouda
• 金额: $ 107.23万
• 依托单位: IMMUNICOM, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-08 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10483880
• 关键词: Address; Advanced Malignant Neoplasm; Adverse effects; Adverse event; Aftercare; Antimitotic Agents; Antitumor Response; Apoptosis; Applications Grants; Blood; Blood Component Removal; Breast Cancer Patient; Cancer Etiology; Cancer Patient; Canis familiaris; Cause of Death; Certification; Cessation of life; Chemotherapy-Oncologic Procedure; Clinical; Clinical Data; Clinical Research; Clinical Trials; Comprehensive Cancer Center; Data; Devices; Dose; ERBB2 gene; Eastern Cooperative Oncology Group; Effectiveness; Enrollment; Estrogen receptor positive; European Organization for Research and Treatment of Cancer; Evaluation; Event; Excision; Flow Cytometry; Goals; Hand; Health Status; Hormones; Image; Immune; Immune response; Immune system; Immunohistochemistry; Immunotherapy; Incidence; Investigation; Israel; Magnetic Resonance Imaging; Malignant Neoplasms; Measures; Mediating; Medical; Medical Device; Medicine; Meleagris gallopavo; Metastatic breast cancer; Monitor; Neoplasm Circulating Cells; Nivolumab; Non-Small-Cell Lung Carcinoma; Oncology; Outcome; Patient-Focused Outcomes; Patients; Performance; Phase; Physician Executives; Plasma; Poland; Population; Procedures; Process; Prognosis; Progression-Free Survivals; Protocols documentation; Quality of life; Refractory; Resistance; Safety; Sampling; Secure; Small Business Innovation Research Grant; Solid; Solid Neoplasm; System; T-Lymphocyte; TNF gene; TNFRSF1A gene; Technology; Testing; Therapeutic; Tissues; Tumor Burden; Tumor Markers; Validation; Walking; Whole Blood; Woman; Work; advanced breast cancer; advanced disease; arm; base; blood filtration; chemotherapy; clinical efficacy; cohort; college; commercialization; comparative; cytokine; design; efficacy study; follow-up; grasp; hormone therapy; immunoregulation; improved; instrument; malignant breast neoplasm; melanoma; neoplastic cell; novel; pre-clinical; primary outcome; programmed cell death ligand 1; programmed cell death protein 1; programs; recruit; research clinical testing; response; response biomarker; secondary outcome; success; treatment response; triple-negative invasive breast carcinoma; tumor; tumor necrosis factor-alpha inhibitor

Abstract: Immunicom is focusing its clinical efforts on validating a first-of-its-kind, breakthrough immunotherapy device for treating a wide range of solid tumor cancers. The device, a subtractive immunopheresis column, specifically reduces circulating soluble receptors for TNF-α (sTNF-Rs) that inhibit TNF-α’s tumoricidal and immunomodulatory activity . This therapeutic approach is designed to enhance the patient’s own innate humoral immune response. Immunicom’s goal is to demonstrate this immunotherapy option for patients with refractory/late stage cancers, that provides more effective outcomes in terms of progression free survival, while maintaining quality of life measures while on therapy. Immunicom’s clinical program is to develop its immunopheresis technology, in combination with best treatment practices for cancer patients, using today’s most advanced therapy options. Immunicom is proposing a trial of the LW-02 immunopheresis device, at Baylor College of Medicine, for treating refractory, metastatic hormone resistant breast cancer. Patients with ER+/Her2- breast cancers that have failed both hormonal therapy, and chemotherapy, often have few choices for continuing therapy, resulting in an unacceptably poor 5 year outcome for most of these patients. Immunicom is proposing an exploratory study in 12 subjects to primarily evaluate safety and tolerability of its immunotherapy LW-02 device in this breast cancer population. Efficacy will focus on pull down of sTNF-Rs from the patient’s circulating blood. Breast cancer patients that have failed at least two lines of hormone therapy, and one to two lines of chemotherapy will be recruited to receive monotherapy with the LW-02 device, over a four week period, then in combination with eribulin chemotherapy, for an additional 12 weeks. Throughout treatment, patients will be monitored for reduction of circulating sTNF-Rs and adverse events. Objective response/clinical benefit will be exploratory; quality-of-life/clinical function, circulating tumor cells and markers of an immunologic response (including in tissue) will be evaluate too. Clinical response to treatment/tumor burden will be monitored by RECIST v1.1/iRECIST criteria (MRI/CT). Follow-up for up to 1 year will include evaluating subjects for progression free survival (PFS), best overall response (BOR), overall response rate (ORR), and overall survival. This exploratory study will provide critical safety and effectiveness data in refractory ER+/HER2- breast cancer, for Immunicom to pursue a larger efficacy study in this specific cohort of patients and expand on the encouraging body of safety, tolerability and effectiveness data emanating from ongoing studies in TNBC, NSCLC, melanoma and other solid tumor. This trial will demonstrate if immunopheresis could be a therapeutic option for treating refractory, hormone resistant breast cancer, alone or with chemotherapy regimens. With breast cancer the second most common cancer and leading cause of death in women, additional therapeutic options are needed to provide better outcomes for patients with advanced disease.

抽象的： Immunicom 的临床工作重点是验证首个突破性免疫治疗设备 该设备是一种消减免疫分离柱，可治疗多种实体瘤癌症。 循环减少 TNF-α (sTNF-R) 的可溶性受体，从而抑制 TNF-α 的杀肿瘤作用 这种治疗方法旨在增强患者自身的先天体液活性。 Immunicom 的目标是向患有以下疾病的患者展示这种免疫治疗选择。 难治性/晚期癌症，在无进展生存方面提供更有效的结果，同时 Immunicom 的临床计划旨在开发其在治疗期间维持生活质量的指标。 免疫分离技术结合癌症患者的最佳治疗实践，使用当今最先进的技术 先进的治疗选择。 Immunicom 提议在贝勒医学院试验 LW-02 免疫分离装置，用于治疗 治疗失败的难治性、转移性激素抵抗性乳腺癌患者。 激素疗法和化疗通常没有什么选择可以继续治疗，从而导致 对于这些患者中的大多数来说，5 年结果不佳，令人无法接受。 Immunicom 提议对 12 名受试者进行一项探索性研究，主要评估其安全性和耐受性 免疫疗法 LW-02 装置在乳腺癌人群中的功效将集中于从 sTNF-R 中去除。 至少两种激素治疗失败的乳腺癌患者的循环血液，以及 将招募一到两种化疗方案来接受 LW-02 装置的单一疗法，超过 4 种方案 周，然后与艾日布林化疗相结合，再持续 12 周。 将监测患者循环 sTNF-R 的减少和不良事件。 益处将是探索性的；生活质量/临床功能、循环肿瘤细胞和免疫标志物 还将评估对治疗/肿瘤负荷的临床反应。 根据 RECIST v1.1/iRECIST 标准 (MRI/CT)，随访将包括评估受试者的情况。 无进展生存期 (PFS)、最佳总体缓解 (BOR)、总体缓解率 (ORR) 和总体生存期。 这项探索性研究将为难治性 ER+/HER2- 乳腺癌提供关键的安全性和有效性数据， Immunicom 在这一特定患者群体中开展更大规模的疗效研究，并扩大鼓励力度 来自 TNBC、NSCLC、黑色素瘤正在进行的研究的大量安全性、耐受性和有效性数据 该试验将证明免疫去除术是否可以作为治疗选择。 难治性、激素抵抗性乳腺癌，单独或与乳腺癌联合化疗。 女性第二大常见癌症和主要原因，需要额外的治疗选择 为晚期疾病患者提供更好的治疗结果。