Go to JCI Insight
  • About
  • Editors
  • Consulting Editors
  • For authors
  • Publication ethics
  • Publication alerts by email
  • Advertising
  • Job board
  • Contact
  • Clinical Research and Public Health
  • Current issue
  • Past issues
  • By specialty
    • COVID-19
    • Cardiology
    • Gastroenterology
    • Immunology
    • Metabolism
    • Nephrology
    • Neuroscience
    • Oncology
    • Pulmonology
    • Vascular biology
    • All ...
  • Videos
    • ASCI Milestone Awards
    • Video Abstracts
    • Conversations with Giants in Medicine
  • Reviews
    • View all reviews ...
    • The cGAS-STING pathway: DNA sensing in health and disease (Jun 2026)
    • Neurodegeneration (Mar 2026)
    • Clinical innovation and scientific progress in GLP-1 medicine (Nov 2025)
    • Pancreatic Cancer (Jul 2025)
    • Complement Biology and Therapeutics (May 2025)
    • Evolving insights into MASLD and MASH pathogenesis and treatment (Apr 2025)
    • Microbiome in Health and Disease (Feb 2025)
    • View all review series ...
  • Viewpoint
  • Collections
    • In-Press Preview
    • Clinical Research and Public Health
    • Research Letters
    • Letters to the Editor
    • Editorials
    • Commentaries
    • Editor's notes
    • Reviews
    • Viewpoints
    • 100th anniversary
    • Top read articles

  • Current issue
  • Past issues
  • Specialties
  • Reviews
  • Review series
  • ASCI Milestone Awards
  • Video Abstracts
  • Conversations with Giants in Medicine
  • In-Press Preview
  • Clinical Research and Public Health
  • Research Letters
  • Letters to the Editor
  • Editorials
  • Commentaries
  • Editor's notes
  • Reviews
  • Viewpoints
  • 100th anniversary
  • Top read articles
  • About
  • Editors
  • Consulting Editors
  • For authors
  • Publication ethics
  • Publication alerts by email
  • Advertising
  • Job board
  • Contact
Top
  • View PDF
  • Download citation information
  • Send a comment
  • Terms of use
  • Standard abbreviations
  • Need help? Email the journal
  • Top
  • Abstract
  • Supplemental material
  • Version history
  • Article usage
  • Citations to this article

Advertisement

Clinical Research and Public HealthIn-Press PreviewClinical ResearchHematologyOncology Open Access | 10.1172/JCI207391

A single-arm prospective phase I trial of 68Ga-PFBC01 PET/CT for multiple myeloma B cell maturation antigen imaging

Tingfei Gu,1 Zhao Chen,1 Bo Tang,2 Tianyao Wang,1 Qi Yang,1 Huihui Liu,2 Zeyin Liang,3 Qian Wang,3 Yang Zhang,2 Yuhua Sun,2 Mingyi Di,2 Tingting Yuan,1 Yongkang Qiu,1 Yimeng Du,4 Lele Song,1 Shengnan Wu,1 Wei Wang,5 Xiaojie Xu,4 Yujun Dong,2 and Lei Kang1

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Gu, T. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Chen, Z. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Tang, B. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Wang, T. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Yang, Q. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Liu, H. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Liang, Z. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Wang, Q. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Zhang, Y. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Sun, Y. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Di, M. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Yuan, T. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Qiu, Y. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Du, Y. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Song, L. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Wu, S. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Wang, W. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Xu, X. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Dong, Y. in: PubMed | Google Scholar

1Department of Nuclear Medicine, Peking University First Hospital, Beijing, China

2Department of Hematology, Peking University First Hospital, Beijing, China

3Department of Hematology, Peking University First Hospital, Beijing, China

4Department of Genetic Engineering, Beijing Institute of Biotechnology, Beijing, China

5Department of Pathology, Peking University First Hospital, Beijing, China

Find articles by Kang, L. in: PubMed | Google Scholar

Published June 30, 2026 - More info

J Clin Invest. https://doi.org/10.1172/JCI207391.
Copyright © 2026, Gu et al. This work is licensed under the Creative Commons Attribution 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.
Published June 30, 2026 - Version history
View PDF
Abstract

BACKGROUND. B cell maturation antigen (BCMA) is a key therapeutic target in multiple myeloma (MM), yet its whole-body in vivo distribution and role in disease assessment remain incompletely defined. We aimed to evaluate the safety, diagnostic performance, and clinical utility of a novel BCMA-targeted PET tracer, 68Ga-PFBC01, in patients with plasma cell disorders.

METHODS. We conducted a single-center, prospective, single-arm phase I trial (ClinicalTrials.gov NCT06717113). Fifty patients underwent 68Ga-PFBC01 PET/CT, including 40 with paired 18F-FDG PET/CT for head-to-head comparison. Primary outcomes included diagnostic performance (sensitivity, specificity, PPV, NPV, and inter-reader agreement). Secondary outcomes included correlations with clinical biomarkers, treatment response assessment, impact on clinical decision-making, and safety.

RESULTS.68Ga-PFBC01 PET/CT demonstrated superior diagnostic performance compared with 18F-FDG PET/CT (sensitivity 96.9% vs 84.6%; specificity 71.4% vs 60.0%). Quantitative PET-derived tumor burden correlated with M protein (R = 0.325, P = 0.026), free light chains (R = 0.340–0.437, P ≤ 0.015), soluble BCMA (R = 0.433, P = 0.050), and bone marrow plasma cells (R = 0.682, P < 0.001). Imaging findings altered clinical management in multiple cases, enabling both therapy escalation and de-escalation. Blood-pool uptake strongly correlated with soluble BCMA (R = 0.899, P < 0.001) and overall disease burden (R = 0.736, P < 0.001). No serious tracer-related adverse events were observed; two patients (4%) experienced mild events.

CONCLUSION.68Ga-PFBC01 PET/CT provides biologically specific, whole-body assessment of MM, outperforming 18F-FDG and enabling integrated evaluation of tumor burden and systemic disease activity, with direct implications for clinical decision-making.

TRIAL REGISTRATION. ClinicalTrials.gov NCT06717113.

FUNDING. National Natural Science Foundation of China (82472018, 82402320) to Prof. Lei Kang, 82402320 to Dr. Tianyao Wang); Beijing Nova Program (20240484725) to Prof. Lei Kang; National High Level Hospital Clinical Research Funding (Interdisciplinary Research Project of Peking University First Hospital, 2024IR07, Scientific and Technological Achievements Transformation Incubation Guidance Fund Project of Peking University First Hospital, 2025CX38, 2024CX18) to Prof. Lei Kang.

Graphical Abstract
graphical abstract
Supplemental material

View Unedited blot and gel images

View

View Trial Protocol (Chinese version)

View Trial Protocol (English version)

Version history
  • Version 1 (June 30, 2026): In-Press Preview

Article tools

  • View PDF
  • Download citation information
  • Send a comment
  • Terms of use
  • Standard abbreviations
  • Need help? Email the journal

Metrics

  • Article usage
  • Citations to this article

Go to

  • Top
  • Abstract
  • Supplemental material
  • Version history
Advertisement
Advertisement

Copyright © 2026 American Society for Clinical Investigation
ISSN: 0021-9738 (print), 1558-8238 (online)

Sign up for email alerts