A Clinical Trial Evaluating the Safety Tolerability, Radiation Absorption Dose, Distribution, PET Imaging and Histological Expression of 68Ga-NOTA-SCH001 in Patients With Multiple Myeloma

Multiple myeloma is the second most common hematologic malignancy in adults, and no curative treatment currently exists. With the development of monoclonal antibodies for tumor therapy, identifying tumor-specific biomarkers has become a prerequisite for pre- and post-treatment evaluation. CD38, which is abnormally elevated in 95% to 100% of malignant plasma cells but relatively low in normal cells, serves as a biomarker for multiple myeloma. In clinical practice, CD38 expression is typically detected through flow cytometry and microscopic examination of bone marrow biopsy samples. However, biopsies are invasive and prone to false-negative results in cases of heterogeneity or small lesion samples, whereas whole-body imaging methods allow non-invasive assessment of target expression.

[¹⁸F]FDG PET/CT imaging is one of the most commonly used techniques in multiple myeloma. However, its diagnostic application is limited by false-negative results due to low hexokinase 2 expression in myeloma cells. Additionally, it fails to provide accurate molecular information, such as CD38 expression in cells. Therefore, this study aims to develop a more specific and stable molecular imaging probe, ⁶⁸Ga-NOTA-SCH001, to non-invasively visualize CD38 expression and monitor responses to CD38-targeted therapy in real time. This approach may also contribute to the formulation and optimization of clinical treatment strategies.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma (MM)
• Intervention / Treatment: Diagnostic test: Flow cytometry

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. The subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements;

  2. Over 18 years old, male or female;

  3. Patients diagnosed with multiple myeloma;

  4. ECOG score is 0-1; The expected survival time is not less than 3 months;

  5. Women of childbearing age need to undergo urine pregnancy test, and enrolled patients must be negative for pregnancy test;

  6. For fertile female patients or male patients with fertile partners, agree to remain abstinent during the study period (no

Or use one or more contraceptive methods with a failure rate of less than 1% per year for at least one year after the end of the study.

7. CD38 monoclonal antibody therapy was not used before enrollment in this study.

Exclusion Criteria:

• General situation

  • Those who are unable to perform visits, or receive relevant tests, or treatment in accordance with the clinical trial protocol;
  • Can not tolerate venous puncture blood collection;
  • Patients with serious diseases or other malignant tumors, except those that the researchers determined to be in stable control;
  • Known severe allergy to SCH001, similar drugs or excipients;

Laboratory examination

• Serum virology test: any of the results of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis specific antibodies

Positive or HIV-negative antibodies cannot be determined;

• Fasting blood glucose >11.1mmol/L;

other

• No active infection
• Drug/alcohol abuse, severe mental disorders;
• Patients with claustrophobia, emotional instability, acute persistent spasms, or inability to keep their arms up and lie flat for 30 minutes;

Participants in any other clinical trial within 3 months prior to screening;

• Women who are pregnant or breastfeeding;
• The investigator did not consider it appropriate to participate in this clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-NOTA-SCH001 PET/CT imaging	Diagnostic test: Flow cytometry; CD38 Flow cytometry testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PET/CT imaging SUV value	0-30minutes、60minutes、120minutes

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 2024-MI- 68Ga-NOTA-SCH001-34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No