New imaging agent lets doctors watch Cancer-Fighting cells in action
NCT ID NCT07280793
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new PET imaging agent called 68Ga-NOTA-BCMA to see if it can safely and accurately show where anti-BCMA CAR-T cells go in the body and how long they last. Ten adults with multiple myeloma who are scheduled for CAR-T therapy will receive the tracer and undergo PET/CT scans. The goal is to gather information on the tracer's distribution and safety, not to treat the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?