CAR-T Cell Efficacy With Molecular Imaging in Multiple Myeloma

NCT07280793 | Not Yet Recruiting Early Phase 1

• 1 other identifier: XYFY2025-KL519-01
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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. Preclinical data robustly support its specific binding, favorable pharmacokinetics, and excellent safety profile, warranting its advancement into clinical studies.

Conditions

BCMA-targeted PET Imaging; Non-invasive CAR-T Cell Monitoring; 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Day 6±2 and Day 11±2 post-CAR-T infusion.

• Safety and Tolerability of 68Ga-NOTA-BCMA

  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

  Day 6±2 and Day 11±2 post-CAR-T infusion.

Study Arms (1)

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.

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

Interventions

BCMA-Targeting CAR-T Cell Therapy OTHER

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.

68Ga-NOTA-BCMA

PET/CT Imaging DEVICE

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.

68Ga-NOTA-BCMA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Officials

• Xueyan Zhou, M.D., Ph.D.

  Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueyan Zhou, M.D., Ph.D.

CONTACT

15105200571; zxy851107@xzhmu.edu.cn

Jiang Cao

CONTACT

13852432263; zimu05067@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 12, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share