89Zr-labeled NY008 PET Imaging in Patients

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affiliated Hospital of Jiangnan University

Criteria

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.