Clinical trial · Interventional
CAR-T Cell Efficacy With Molecular Imaging in Multiple Myeloma
Visualizing CAR-T Cell Therapy in Multiple Myeloma Using a BCMA-Targeted PET Probe
NCT07280793CI-TRIAL-00099109not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BCMA-targeted PET Imaging | — | UNRESOLVED | — |
| CAR-T Cell Biodistribution and Persistence | — | UNRESOLVED | — |
| GMP-compliant Radiopharmaceutical Preparation | — | UNRESOLVED | — |
| Non-invasive CAR-T Cell Monitoring | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCMA-Targeting CAR-T Cell Therapy | Other | — | UNRESOLVED |
| PET/CT Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NOTA-BCMA
- 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.
- interventionNames
- Other: BCMA-Targeting CAR-T Cell Therapy
- Device: PET/CT Imaging
Primary outcomes (2)
- measure
- Biodistribution of 68Ga-NOTA-BCMA
- timeFrame
- 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.
- description
- 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.
- measure
- Pharmacokinetic assessment of 68Ga-NOTA-BCMA: measurement of elimination half-life (t1/2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.