Visualizing CAR-T Cell Therapy in Multiple Myeloma Using a BCMA-Targeted PET Probe
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Biodistribution of 68Ga-NOTA-BCMA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**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.
排除标准
- •**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.
结局指标
主要结局
Biodistribution of 68Ga-NOTA-BCMA
时间窗: 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.
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)
时间窗: 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).
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.
次要结局
- CAR-T Cell Expansion and Persistence(Day 6±2 and Day 11±2 post-CAR-T infusion.)
- CAR-T Cell Immunophenotyping(Day 6±2 and Day 11±2 post-CAR-T infusion.)
- Safety and Tolerability of 68Ga-NOTA-BCMA(Vital signs: pre-injection and 2 hours (±1h) post-injection of 68Ga-NOTA-BCMA. Other safety assessments: throughout the study, with a follow-up at Day 28±2 after the last tracer dose.)
研究者
Kai Lin Xu，MD
Chief physician
Xuzhou Medical University