Non-invasive CAR-T Cell MonitoringEarly Phase 1NCT07280793
CAR-T Cell Efficacy With Molecular Imaging in Multiple Myeloma
A Early Phase 1 study testing BCMA-Targeting CAR-T Cell Therapy and PET/CT Imaging in people with Non-invasive CAR-T Cell Monitoring and BCMA-targeted PET Imaging, run by Xuzhou Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-invasive CAR-T Cell Monitoring, BCMA-targeted PET Imaging, CAR-T Cell Biodistribution and Persistence
- What is being tested?
- BCMA-Targeting CAR-T Cell Therapy and PET/CT Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 17 Dec 2025to 30 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Visualizing CAR-T Cell Therapy in Multiple Myeloma Using a BCMA-Targeted PET Probe
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.
Read the detailed 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.
- Conditions
- Non-invasive CAR-T Cell Monitoring, BCMA-targeted PET Imaging, CAR-T Cell Biodistribution and Persistence, GMP-compliant Radiopharmaceutical Preparation
- Being tested
- BCMA-Targeting CAR-T Cell Therapy, PET/CT Imaging
- Keywords
- ⁶⁸Ga-NOTA-BCMA, BCMA CAR-T cell imaging, BCMA PET tracer, Radiolabeled BCMA peptide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA-Targeting CAR-T Cell TherapyOther
Patient T-cells are harvested and genetically engineered to express chimeric antigen receptors (CARs) targeting B-cell maturation antigen (BCMA). These modified CAR-T cells specifically recognize and eliminate multiple myeloma cells expressing BCMA. Following reinfusion, the CAR-T cells undergo antigen-stimulated proliferation, establishing sustained antitumor immune activity.
PET/CT ImagingDevice
A low-dose PET/CT scan will be performed 60 minutes post-administration of the agent. Low-dose CT is only utilized for anatomic localization and PET attenuation correction, and the radiation dose involved is substantially lower than that of conventional CT.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: BCMA-Targeting CAR-T Cell Therapy; Device: PET/CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Secondary outcomes (3)
CAR-T Cell Expansion and Persistence
Quantitative measurement of CAR-T copy number in peripheral blood using qPCR.
Measured: Day 6±2 and Day 11±2 post-CAR-T infusion.
Safety and Tolerability of 68Ga-NOTA-BCMA
The number of participants with adverse events is assessed via the NCI Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
The number of participants with abnormal vital signs is assessed using electronic thermometers, electronic sphygmomanometers, electronic monitors (for heart rate), and manual chest rise counting.
The number of participants with abnormal physical examination findings is assessed in accordance with standard clinical protocols.
The number of participants with laboratory abnormalities (including hematology, urinalysis, coagulation, and blood biochemistry) is assessed using automated analyzers (for hematology, coagulation, and blood biochemistry), dry chemistry analyzers, and sediment microscopes (for urinalysis).
The number of participants with abnormal electrocardiogram (ECG) findings is assessed via 12-lead electrocardiograph testing.
Measured: 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.
CAR-T Cell Immunophenotyping
Characterization of CAR-T cell populations in peripheral blood using flow cytometry.
Measured: Day 6±2 and Day 11±2 post-CAR-T infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start17 Dec 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-invasive CAR-T Cell MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Lin Xu，MD, Xuzhou Medical University
- Investigators
- Xueyan Zhou, M.D., Ph.D., Principal investigator, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280793
- Sponsor's protocol ID
- XYFY2025-KL519-01
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualizing CAR-T Cell Therapy in Multiple Myeloma Using a BCMA-Targeted PET Probe
- ClinicalTrials.gov ID
- NCT07280793
- Acronym / sponsor ID
- XYFY2025-KL519-01
- Conditions
- Non-invasive CAR-T Cell Monitoring, BCMA-targeted PET Imaging, CAR-T Cell Biodistribution and Persistence, GMP-compliant Radiopharmaceutical Preparation
- Keywords
- ⁶⁸Ga-NOTA-BCMA, BCMA CAR-T cell imaging, BCMA PET tracer, Radiolabeled BCMA peptide
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 17 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NOTA-BCMA | Experimental | Other: BCMA-Targeting CAR-T Cell Therapy, Device: PET/CT ImagingEligible subjects enrolled in the study will receive a predetermined dose of the 68Ga-NOTA-BCMA radiopharmaceutical preparation as part of the investigational imaging protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Inclusion Criteria
Key exclusion criteria (9 listed)
- Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCMA-Targeting CAR-T Cell TherapyPatient T-cells are harvested and genetically engineered to express chimeric antigen receptors (CARs) targeting B-cell maturation antigen (BCMA). These modified CAR-T cells specifically recognize and eliminate multiple myeloma cells expressing BCMA. Following reinfusion, the CAR-T cells undergo antigen-stimulated proliferation, establishing sustained antitumor immune activity. | Other | 68Ga-NOTA-BCMA |
| PET/CT ImagingA low-dose PET/CT scan will be performed 60 minutes post-administration of the agent. Low-dose CT is only utilized for anatomic localization and PET attenuation correction, and the radiation dose involved is substantially lower than that of conventional CT. | Device | 68Ga-NOTA-BCMA |
Primary outcome
Biodistribution of 68Ga-NOTA-BCMA
Time frame: 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)
Time frame: 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.
3 secondary outcomes
CAR-T Cell Expansion and Persistence
Time frame: Day 6±2 and Day 11±2 post-CAR-T infusion.
Safety and Tolerability of 68Ga-NOTA-BCMA
Time frame: 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.
CAR-T Cell Immunophenotyping
Time frame: Day 6±2 and Day 11±2 post-CAR-T infusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xueyan Zhou, M.D., Ph.D. principal investigator
Xuzhou Medical University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BCMA-Targeting CAR-T Cell Therapy and PET/CT Imaging in people with Non-invasive CAR-T Cell Monitoring and BCMA-targeted PET Imaging, run by Xuzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xueyan Zhou, M.D., Ph.D. (15105200571, zxy851107@xzhmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodistribution of 68Ga-NOTA-BCMA (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.