CAR-T Cell Efficacy With Molecular Imaging in Multiple Myeloma

Xuzhou Medical University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: GMP-compliant Radiopharmaceutical Preparation; BCMA-targeted PET Imaging; CAR-T Cell Biodistribution and Persistence; Non-invasive CAR-T Cell Monitoring

Treatments: Other: BCMA-Targeting CAR-T Cell Therapy; Device: PET/CT Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT07280793

XYFY2025-KL519-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

68Ga-NOTA-BCMA

Experimental group

Description:

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.

Treatment:

Device: PET/CT Imaging

Other: BCMA-Targeting CAR-T Cell Therapy