89Zr-labeled NY008 PET Imaging in Patients

Early Phase 1

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: 89Zr-NY008

• Registration Number: NCT05655676
• Lead Sponsor: Affiliated Hospital of Jiangnan University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-25
• Status Verified: 2022-12
• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-15
• Last Update Submitted: 2022-12-15
• Study First Posted: 2022-12-19
• Last Update Posted: 2022-12-19
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
89Zr-NY008	89Zr-NY008	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Affiliated Hospital of Jiangnan University; 🇨🇳 Wuxi, Jiangsu, China