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CD38-TARGETED IMMUNOPET OF MYELOMA: PHASE 2 TRIAL OF CLINICAL APPLICATIONS

CD38 靶向骨髓瘤免疫宠物：临床应用 2 期试验

基本信息

批准号：
10286324
负责人：
Carl Ola Landgren
金额：
$ 59.89万
依托单位：
HOAG MEMORIAL HOSPITAL PRESBYTERIAN
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-01 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10286324
关键词：
Antibodies Biopsy Blood Tests Bone marrow biopsy Cells Clinical Clinical Trials Combined Modality Therapy Detection Detection of Minimal Residual Disease Disease Funding Opportunities Future Goals Histologic Human Image ImmunoPET Immunoglobulins Investigation Laboratories Measurement Measures Membrane Proteins Memorial Sloan-Kettering Cancer Center Methods Monitor Monoclonal Antibodies Multiple Myeloma PET/CT scan Patient Care Patient Monitoring Patient imaging Patients Phase Phase I Clinical Trials Phase II Clinical Trials Plasma Cell Neoplasm Plasma Cells Positron-Emission Tomography Prognostic Marker Proteins Radiochemistry Radioimmunotherapy Radiolabeled Research Personnel Residual Tumors Safety Selection for Treatments Serum Site Surface Therapeutic Agents Tracer Translations Tumor Burden United States Visualization Work base blind burden of illness cancer imaging clinical application clinical care clinically significant design dosimetry early phase trial experience first-in-human fluorodeoxyglucose positron emission tomography human imaging imaging agent imaging modality individual patient innovation multiple myeloma M Protein novel outcome forecast phase I trial phase II trial preclinical imaging predicting response response targeted imaging theranostics treatment response tumor uptake virtual

项目摘要

Project Summary / Abstract Multiple myeloma is a plasma cell neoplasm with poor prognosis but promising future treatment. Current measurements of myeloma disease burden are suboptimal, and this limits clinical care. We have completed a first-in-human trial of CD38-targeted immunoPET with the radiolabeled anti-CD38 monoclonal antibody, 89Zr- DFO-daratumumab, which very successfully visualized myeloma disease burden as never done before. This proposal is a phase 2 clinical trial to identify clinically valuable applications of CD38-targeted immunoPET in patients with multiple myeloma. Our central hypothesis is that targeted imaging of CD38, which is expressed on the surface of virtually every myeloma cell, will allow clinically valuable non-invasive immuno-PET imaging of patients with myeloma. This would be a transformative strategy for the measurement of myeloma tumor burden, selection of therapeutic agents, and monitoring of treatment response. In the first aim of the study, we will determine the correlation between tumor uptake of 89Zr-DFO-daratumumab with clinically standard laboratory and imaging measurement of myeloma, including patient serum M protein concentration, percentage of plasma cells on bone marrow biopsy, FDG PET/CT, and whole-body MR. Because current approaches to assessing myeloma tumor burden are sub-optimal, developing a method to sensitively visualize and localize myeloma could have a profound impact on patient care. In the second aim of the study, we will determine if tumor uptake of 89Zr-DFO-daratumumab predicts response to daratumumab-containing combination therapy. Not all patients respond to daratumumab therapy; thus, a method of predicting response would be valuable for selection of therapy in individual patients. In the third aim, we will determine if 89Zr-DFO-daratumumab imaging following daratumumab-containing combination therapy can detect clinically significant residual disease. Detection of minimal residual disease (MRD) following therapy continues to grow in importance as a prognostic marker and endpoint in myeloma clinical trials. A method of visualizing and localizing residual disease would impact patient care, as well as enhance trials of developing myeloma therapies. The ultimate goal of this work would be the identification of clinically valuable applications for 89Zr-DFO- daratumumab immunoPET and, if successful, advancement toward FDA approval of this agent.

项目摘要/摘要