A Molecular Probe Targeting BCMA for the Clinical Diagnosis of Multiple Myeloma

NCT06717113 | Recruiting Early Phase 1 DMC

• 1 other identifier: PekingUFH-MM-BC1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Multiple Myeloma and Malignant Plasma Cell Neoplasms

Keywords

multiple myeloma; molecular probe; Immuno-PET

Outcome Measures

Primary Outcomes (1)

• MM patients will be recruited to undergo PET/CT imaging using 68Ga-NB381 and 18F-FDG to evaluate and verify that the imaging agent 68Ga-NB381 can safely and effectively identify lesions.

  This study will investigate the radioactive uptake of 68Ga-BC1 in lesion sites of multiple myeloma patients and evaluate the ability of 68Ga-BC1 to detect BCMA overexpression in these patients. According to the admission and exclusion criteria, patients who meet the conditions are screened. After the patients were enrolled, baseline examination information was collected, including blood routine, blood biochemistry, tumour markers, histopathological diagnosis results, imaging diagnosis results, etc. For the Follow-up information, the patient's bone marrow aspirate or pathological tissue biopsy, laboratory test results (blood monoclonal M protein, 24-hour urine light chain, etc.), bone scintigraphy, CT or MR and other imaging examination results would be collected.

  All PET/CT images will be reviewed by physicians, and a unified diagnostic opinion will be provided within 3 days after adminis. After imaging, patients will be scheduled for follow-up visits every 3 months, with a follow-up period of at least 12 months.

Study Arms (2)

68Ga-BC1 PET/CT diagnosis

EXPERIMENTAL

Drug: 68Ga-BC1

18F-FDG PET/CT diagnosis

ACTIVE COMPARATOR

Drug: 18F-FDG

Interventions

18F-FDG DRUG

Prior to the examination, patients will be required to fast for at least 6 hours. 18F-FDG (0.05-0.1 mCi/kg) will be intravenously injected, and one hour after the injection, head and torso imaging will be performed using a Shanghai United Imaging uMI 780 PET/CT scanner, covering the region from the top of the head to the upper third of the thigh. The patient will lie supine and breathe calmly during the procedure. After image acquisition, the data will be reconstructed using the OSEM method to generate coronal, sagittal, transverse, and PET/CT fusion images.

18F-FDG PET/CT diagnosis

68Ga-BC1 DRUG

The prepared and quality-controlled 68Ga-BC1 (0.05-0.1 mCi/kg) will be intravenously injected into the patient. Two hours after the injection, whole-body imaging will be performed using a Shanghai United Imaging uMI 780 PET/CT scanner, covering the region from the top of the head to the mid-thigh. If any indeterminate lesions are found during the routine imaging, delayed imaging will be performed for further differentiation. The patient will lie supine and breathe calmly during the procedure. After image acquisition, the data will be reconstructed using the OSEM method to generate coronal, sagittal, transverse, and PET/CT fusion images.

68Ga-BC1 PET/CT diagnosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected multiple myeloma patients scheduled for bone marrow aspiration or tissue biopsy within the past 3 months; able to fully understand and voluntarily participate in the study, with signed informed consent; able to cooperate with the examination.
• Diagnosed symptomatic multiple myeloma patients; able to fully understand and voluntarily participate in the study, with signed informed consent; able to cooperate with the examination.

You may not qualify if:

• Pregnant women; individuals unable to understand the examination process or who are unable to cooperate.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (2)

Department of Nuclear Medicine, Peking University First Hospital

Beijing, Beijing Municipality, 010000, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100000, China

ENROLLING BY INVITATION

Related Publications (3)

• 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.

  PMID: 29450576 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.

  PMID: 32826320 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.

  PMID: 34677626 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Lei Kang, M.D.

  Peking University First Hospital

  STUDY CHAIR

• Yujun Dong Dong, M.D.

  Peking University First Hospital

  STUDY DIRECTOR

• Tianyao Wang, Ph.D.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianyao Wang, PhD

CONTACT

9298551137; tianyao.wang@pkufh.com

Tingting Yuan, M.D.

CONTACT

13051707479; biluohtt@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is an interventional clinical trial in which enrolled patients will undergo a comparative analysis using two PET/CT imaging agents: 68Ga-NB381 and 18F-FDG. The two drugs should be given at least one day apart.

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: December 4, 2024
• Study Start: April 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: January 2025-December 2027
• Access Criteria: The ICMJE journals and their readers.

Locations

CN (2)