BCMA-Targeting CAR-T（BCMA 细胞治疗）治疗 Non-invasive CAR-T Cell Monitoring：早期 I 期临床试验

Inclusion Criteria:

* \*\*Inclusion Criteria\*\*

  1. Subjects must voluntarily sign the informed consent form and be able to complete the trial per the protocol requirements.
  2. Age 18 years or older, regardless of gender.
  3. Diagnosed with multiple myeloma and scheduled to receive anti-BCMA CAR-T cell therapy.
  4. ECOG performance status of 0-2; with a life expectancy of not less than 3 months.
  5. Female subjects of childbearing potential must have a negative serum pregnancy test prior to enrollment.
  6. 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\*\*

  1. 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.
  2. History of hypersensitivity to any component of the imaging agent or antibodies, or a known allergic predisposition.
  3. Inability to undergo PET/CT imaging, such as due to claustrophobia or emotional instability.
  4. Current use of anticoagulant therapy or anticipated requirement for such therapy during the study period.
  5. Known allergic or hypersensitivity reactions to biological products or any excipient of the 68Ga-NOTA-BCMA molecular probe.
  6. Active hepatitis B or C infection, or seropositivity for human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody.
  7. Pregnancy, lactation, or intention to become pregnant during the trial period.
  8. Any other condition deemed by the investigator to render the subject unsuitable for trial participation.

主要终点：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. · Baseline (pre-CAR-T), and at Day 6±2, Day 11±2, Day 21±2 post-CAR-T infusion (Scan at 60 minutes post-injection). For the first 3 subjects, additional scans at 30 and 120 minutes post-injection will be performed at baseline.；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. · Baseline: pre-injection, and at 2, 5, 10, 15, 30, 60, 90, 120 minutes post-injection of 68Ga-NOTA-BCMA. (May be omitted for subsequent subjects based on results from the first 5 subjects).
次要终点：CAR-T Cell Expansion and Persistence；Safety and Tolerability of 68Ga-NOTA-BCMA；CAR-T Cell Immunophenotyping

• 68Ga-NOTA-BCMA · EXPERIMENTAL · Eligible subjects enrolled in the study will receive a predetermined dose of the 68Ga-NOTA-BCMA radiopharmaceutical preparation as part of the investigational imaging protocol.

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.