CAR-T Cell Efficacy With Molecular Imaging in Multiple Myeloma

NCT ID: NCT07280793

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-17
• Study Completion Date: 2027-12-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

68Ga-NOTA-BCMA

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.

Group Type: EXPERIMENTAL

BCMA-Targeting CAR-T Cell Therapy

Intervention Type: 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.

PET/CT Imaging

Intervention Type: 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.

Interventions

BCMA-Targeting CAR-T Cell Therapy

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.

Intervention Type: OTHER

PET/CT Imaging

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.

Intervention Type: DEVICE

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kai Lin Xu，MD

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Xuzhou Medical University

Central Contacts

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

Role: CONTACT

zxy851107@xzhmu.edu.cn

15105200571

Jiang Cao

Role: CONTACT

zimu05067@163.com

13852432263

Other Identifiers

XYFY2025-KL519-01

Identifier Type: -

Identifier Source: org_study_id