drugset / Trial / NCT06717113
A Molecular Probe Targeting BCMA for the Clinical Diagnosis of Multiple Myeloma
Non-randomizedCrossoverOpen-labelDiagnostic
Summary
Multiple Myeloma (MM), the second most common hematological malignancy, continues to pose challenges in precise clinical identification. As a potential solution, nuclear medicine immuno-PET imaging has emerged as a promising approach. However, traditional full-length antibody probes suffer from delayed tumor uptake peaks and low target-to-background ratios, limiting their clinical utility. In our study, a peptide or nanobody targeting BCMA was developed by computer-aided designing, which was subsequently radiolabeled with 68Ga to create a novel molecular probe, 68Ga-MM-BC1. This research aims to overcome the diagnostic limitations of MM and may also offer valuable insights for molecular-targeted imaging in other malignant tumors.
Timeline
- Start
- 2025-04-15
- Primary completion
- 2025-12-31
- Completion
- 2028-12
Publications
- Background Kang L, Jiang D, England CG, Barnhart TE, Yu B, Rosenkrans ZT, Wang R, Engle JW, Xu X, Huang P, Cai W. ImmunoPET imaging of CD38 in murine lymphoma models using 89Zr-labeled daratumumab. Eur J Nucl Med Mol Imaging. 2018 Jul;45(8):1372-1381. doi: 10.1007/s00259-018-3941-3. Epub 2018 Feb 15.
- Background Kang L, Li C, Rosenkrans ZT, Engle JW, Wang R, Jiang D, Xu X, Cai W. Noninvasive Evaluation of CD20 Expression Using 64Cu-Labeled F(ab')2 Fragments of Obinutuzumab in Lymphoma. J Nucl Med. 2021 Mar;62(3):372-378. doi: 10.2967/jnumed.120.246595. Epub 2020 Aug 21.
- Background Kang L, Li C, Yang Q, Sutherlin L, Wang L, Chen Z, Becker KV, Huo N, Qiu Y, Engle JW, Wang R, He C, Jiang D, Xu X, Cai W. 64Cu-labeled daratumumab F(ab')2 fragment enables early visualization of CD38-positive lymphoma. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1470-1481. doi: 10.1007/s00259-021-05593-9. Epub 2021 Oct 22.
- Gu T, Chen Z, Tang B, Wang T, Yang Q, Liu H, Liang Z, Wang Q, Zhang Y, Sun Y, Di M, Yuan T, Qiu Y, Du Y, Song L, Wu S, Wang W, Xu X, Dong Y, Kang L. A single-arm prospective phase I trial of 68Ga-PFBC01 PET/CT for multiple myeloma B cell maturation antigen imaging. J Clin Invest. 2026 Jun 30:e207391. doi: 10.1172/JCI207391. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 18F-FDG | Diagnostic / imaging agent | 1.85 mbq/kg | Intravenous |
| Comparator | 18F-FDG | Diagnostic / imaging agent | 3.7 mbq/kg | Intravenous |
| Subject | 68Ga-BC1 | Unknown | 1.85 mbq/kg | Intravenous |
| Subject | 68Ga-BC1 | Unknown | 3.7 mbq/kg | Intravenous |