CAR-T Cell Efficacy With Molecular Imaging in Multiple Myeloma

⁶⁸Ga-NOTA-BCMA is an investigational PET radiopharmaceutical designed for targeted in vivo tracking of BCMA-directed CAR-T cells. Its molecular design incorporates a BCMA-derived peptide, specific for the CAR's scFv, conjugated to the ⁶⁸Ga-chelator NOTA. Preclinical data confirm high target affinity, rapid renal clearance (t₁/₂α=3.30 min, t₁/₂β=33.27 min), and an excellent safety profile with no drug-related toxicities in murine models. The agent is administered as a single IV bolus (4 mCi/80 μg) and must be used within 4 hours of GMP-compliant, on-site radiolabeling.

Inclusion criteria

• **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.
• ECOG performance status of 0-2; with a life expectancy of not less than 3 months.
• Female subjects of childbearing potential must have a negative serum pregnancy test prior to enrollment.
• For female subjects of childbearing potential or male subjects with partners of childbearing potential, agreement to remain abstinent or use one or more forms of contraception with a failure rate of <1% per year during the study period and for at least one year after the study completion.

Exclusion criteria

• **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.
• Current use of anticoagulant therapy or anticipated requirement for such therapy during the study period.
• Known allergic or hypersensitivity reactions to biological products or any excipient of the 68Ga-NOTA-BCMA molecular probe.
• Active hepatitis B or C infection, or seropositivity for human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody.
• Pregnancy, lactation, or intention to become pregnant during the trial period.
• Any other condition deemed by the investigator to render the subject unsuitable for trial participation.