89Zr-labeled NY008 PET Imaging in Patients

Multiple Myeloma Clinical Trial

Official title:

89Zr-labeled NY008 PET Imaging in Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05655676
• Other study ID #: LS2020001
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 25, 2022
• Est. completion date: May 2023

Study information

• Verified date: December 2022
• Source: Affiliated Hospital of Jiangnan University
• Contact: Chunjing Yu
• Phone: 15312238622
• Email: ycj_wxd1978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma

Intervention

Drug:
• 89Zr-NY008
Patients will receive a tracer (5-10mg, IV) dose of 89Zr (2-3mCi) labelled NY008

Locations

Country	Name	City	State
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Jiangnan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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