NCT07280793Not yet recruitingEarly phase 1
CAR-T Cell Efficacy With Molecular Imaging in Multiple Myeloma
Visualizing CAR-T Cell Therapy in Multiple Myeloma Using a BCMA-Targeted PET Probe
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- Dec 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Xuzhou Medical University
- Diseases
- Multiple myeloma
- NCT number
- NCT07280793
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 10
- From Dec 2025 to the primary completion date, Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \*\*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.
Who the study is looking for
- \*\*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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.