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CAR-T Cell Efficacy With Molecular Imaging in Multiple Myeloma

NCT07280793 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-17

No results posted yet for this study

Summary

⁶⁸Ga-NOTA-BCMA is a novel, targeted PET tracer under clinical investigation. It is designed to provide a non-invasive method for monitoring the biodistribution and persistence of BCMA CAR-T cells in patients. Preclinical data robustly support its specific binding, favorable pharmacokinetics, and excellent safety profile, warranting its advancement into clinical studies.

Conditions

  • Non-invasive CAR-T Cell Monitoring
  • BCMA-targeted PET Imaging
  • CAR-T Cell Biodistribution and Persistence
  • GMP-compliant Radiopharmaceutical Preparation

Interventions

OTHER

BCMA-Targeting CAR-T Cell Therapy

Patient T-cells are harvested and genetically engineered to express chimeric antigen receptors (CARs) targeting B-cell maturation antigen (BCMA). These modified CAR-T cells specifically recognize and eliminate multiple myeloma cells expressing BCMA. Following reinfusion, the CAR-T cells undergo antigen-stimulated proliferation, establishing sustained antitumor immune activity.

DEVICE

PET/CT Imaging

A low-dose PET/CT scan will be performed 60 minutes post-administration of the agent. Low-dose CT is only utilized for anatomic localization and PET attenuation correction, and the radiation dose involved is substantially lower than that of conventional CT.

Sponsors & Collaborators

  • Xuzhou Medical University

    lead OTHER

Principal Investigators

  • Xueyan Zhou, M.D., Ph.D. · Xuzhou Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-17
Primary Completion
2027-12-30
Completion
2027-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07280793 on ClinicalTrials.gov