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NOT YET RECRUITING
NCT07280793
EARLY_PHASE1

CAR-T Cell Efficacy With Molecular Imaging in Multiple Myeloma

Sponsor: Xuzhou Medical University

View on ClinicalTrials.gov

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.

Official title: Visualizing CAR-T Cell Therapy in Multiple Myeloma Using a BCMA-Targeted PET Probe

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-12-17

Completion Date

2027-12-30

Last Updated

2025-12-17

Healthy Volunteers

No

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.