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.
**Inclusion Criteria**
Subjects must voluntarily sign the informed consent form and be able to complete the trial per the protocol requirements.
Age 18 years or older, regardless of gender.
Diagnosed with multiple myeloma and scheduled to receive anti-BCMA CAR-T cell therapy.
**Exclusion Criteria**
Participation in another interventional clinical trial, concurrently or within 28 days prior to the first dose in this study. Participation in non-interventional trials is permitted.
History of hypersensitivity to any component of the imaging agent or antibodies, or a known allergic predisposition.
Inability to undergo PET/CT imaging, such as due to claustrophobia or emotional instability.
Single group
BCMA-Targeting CAR-T Cell Therapy
Other interventionPatient 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.
PET/CT Imaging
DeviceA 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.
Biodistribution of 68Ga-NOTA-BCMA
Assessment of tracer uptake in tumor and normal tissues (e.g., brain, liver, heart) by measuring Standardized Uptake Values (SUV) on low-dose PET/CT scans.
Pharmacokinetic assessment of 68Ga-NOTA-BCMA: measurement of elimination half-life (t1/2)
Measure the elimination half-lives of radioactive concentrations in whole blood and plasma at multiple time points to characterize the clearance kinetics of the tracer.
CAR-T Cell Expansion and Persistence
Quantitative measurement of CAR-T copy number in peripheral blood using qPCR.
Safety and Tolerability of 68Ga-NOTA-BCMA
The number of participants with adverse events is assessed via the NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0. The number of participants with abnormal vital signs is assessed using electronic thermometers, electronic sphygmomanometers, electronic monitors (for heart rate), and manual chest rise counting. The number of participants with abnormal physical examination findings is assessed in accordance with standard clinical protocols. The number of participants with laboratory abnormalities (including hematology, urinalysis, coagulation, and blood biochemistry) is assessed using automated analyzers (for hematology, coagulation, and blood biochemistry), dry chemistry analyzers, and sediment microscopes (for urinalysis). The number of participants with abnormal electrocardiogram (ECG) findings is assessed via 12-lead electrocardiograph testing.
CAR-T Cell Immunophenotyping
Characterization of CAR-T cell populations in peripheral blood using flow cytometry.
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