89Zr-labeled NY008 PET Imaging in Patients

This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY008 PET Imaging in patients with multiple myeloma

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: 89Zr-NY008

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Chunjing Yu; Phone Number: 15312238622; Email: ycj_wxd1978@163.com

Study Locations

• China
  • Jiangsu
    • Wuxi, Jiangsu, China, 214000
      • Recruiting
      • Affiliated Hospital of Jiangnan University
      • Contact: Chunjing Yu; Phone Number: 15312238622; Email: ycj_wxd1978@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Older than 18 years old, male or female;
2. Patients diagnosed with relapsing or refractory multiple myeloma；
3. LVEF≥50%；
4. ECOG score 0~2；

Exclusion Criteria:

1. Life expectancy of less than 3 months;
2. Participated in other clinical research within 1 month;
3. Recovery from major trauma (including surgery) within 28 days prior to study treatment;
4. Patients with systemic or locally severe infections, or other serious coexisting diseases;
5. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
6. Patients with autoimmune diseases, including rheumatoid arthritis;
7. Inadequate control of arrhythmias, including atrial fibrillation;
8. Uncontrolled hypertension;
9. Patients with allergies or allergies to any component of the imaging agent or antibody;
10. Patients who cannot undergo PET/CT imaging scan;
11. Syphilis, HBV, HCV, or HIV positive subjects;
12. Male and female subjects of reproductive age cannot take effective contraceptive measures;
13. Pregnant or lactating women;
14. Patients with a history of mental illness or related conditions;
15. Other subjects considered unsuitable by researchers.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 89Zr-NY008	Drug: 89Zr-NY008; Patients will receive a tracer (5-10mg, IV) dose of 89Zr (2-3mCi) labelled NY008

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of tissue distribution of 89Zr-NY008	Biodistribution of 89Zr-NY008 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs will be reported.	7 days

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Jiangnan University

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Multiple Myeloma
• Other Study ID Numbers: LS2020001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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