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Preclinical development of CM-CX1 for the treatment of ovarian clear cell and renal cell carcinomas

CM-CX1治疗卵巢透明细胞癌和肾细胞癌的临床前开发

基本信息

批准号：
10696145
负责人：
Joana M Murad
金额：
$ 76.94万
依托单位：
CELDARA MEDICAL, LLC
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-08 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10696145
关键词：
ARHGEF5 gene Angiogenesis Inhibitors Antibodies Antigens Biological Assay Biological Markers CAR T cell therapy CD19 gene Cause of Death Cell Surface Proteins Cell Therapy Cell surface Cells Cessation of life Clear cell carcinoma Clear cell renal cell carcinoma Clinic Clinical Clinical Research Combination immunotherapy Coupled Cryopreservation Development Diagnosis Disease Dose Drug Side Effects Effectiveness Evaluation Exhibits Goals Hematologic Neoplasms High Prevalence Ideal 1 Immune checkpoint inhibitor Immune system Immunoglobulins Immunooncology Immunotherapy Infiltration Infusion procedures Investigation Killer Cells Legal patent Lymphocyte Malignant Neoplasms Malignant neoplasm of ovary Marketing Maximum Tolerated Dose Modality Mucin 1 protein Newly Diagnosed Normal tissue morphology Organ Ovarian Ovarian Carcinoma Ovarian Clear Cell Tumor Patients Peripheral Blood Mononuclear Cell Phase Process Production Refractory Renal Cell Carcinoma Renal carcinoma Retroviridae Risk Safety Schedule Signal Transduction Site Solid Neoplasm Specificity T-Cell Activation T-Lymphocyte Technology Transfer Therapeutic Time Tissues Toxic effect Tumor Antigens Tyrosine Kinase Inhibitor United States Urogenital Cancer Validation Virus Work antibody inhibitor cancer cell cancer heterogeneity candidate marker cell bank cellular targeting checkpoint therapy chemokine chemotherapy chimeric antigen receptor chimeric antigen receptor T cells cytokine cytotoxic density design effective therapy experience first-in-human genetically modified cells glycoprotein CX 1 immunogenic improved improved outcome in vivo manufacture manufacturing facility mortality mouse model neoplastic neoplastic cell novel novel therapeutic intervention novel therapeutics optimism personalized cancer therapy phase 1 study pre-clinical preclinical development rat KIM-1 protein receptor binding side effect success survival outcome tumor urogenital tract weapons

项目摘要

PROJECT SUMMARY Cancer is one of the leading causes of death worldwide. Over the years, a number of conventional cytotoxic approaches for neoplastic diseases has been developed. However, due to their limited effectiveness in accordance with the heterogeneity of cancer cells, there is a constant search for therapeutic approaches with improved outcome, such as immunotherapy that utilizes and enhances the normal capacity of the patient's immune system. Of note, renal cell carcinoma and ovarian cancer are considered immunogenic, or “hot” cancers, in that tumors are infiltrated with T cells. This provides optimism that the immune system can be harnessed to be a potent and durable weapon against these cancers. Chimeric antigen receptor (CAR) T-cell therapy represents a major advancement in personalized cancer treatment. In this strategy, a patient's own T cells are genetically engineered to express a synthetic receptor that binds a tumor antigen. We have developed a CAR T cell therapy, CM-CX1, designed to target a very specific marker (TIM-1) in renal and ovarian cancers. Expression of TIM-1 in healthy tissues is limited to absent. The goal of this Fast Track proposal is to finalize the preclinical work required for CM-CX1 filing of an IND for first-in-human evaluation.

项目摘要癌症是全球主要的死亡原因之一。多年来，许多常规的细胞毒性药物已经开发了用于肿瘤疾病的方法。然而，由于其有限的效力，根据癌细胞的异质性，人们不断寻找治疗方法，改善的结果，如利用和增强患者的正常能力的免疫疗法，免疫系统值得注意的是，肾细胞癌和卵巢癌被认为是免疫原性的，或“热”的。癌症，因为肿瘤被T细胞浸润。这提供了乐观的看法，免疫系统可以成为对抗这些癌症的强大而持久的武器。嵌合抗原受体（CAR）T细胞疗法代表了个性化癌症的重大进展治疗在这一策略中，患者自身的T细胞被基因工程化以表达合成受体与肿瘤抗原结合我们已经开发了一种CAR T细胞疗法CM-CX 1，旨在靶向一种非常肾癌和卵巢癌的特异性标志物（TIM-1）。TIM-1在健康组织中的表达仅限于无托叶本快速通道提案的目标是完成CM-CX 1备案所需的临床前工作，用于首次人体评价的IND。