89Zr-labeled NY008 PET Imaging in Patients

Affiliated Hospital of Jiangnan University

Status and phase: Enrolling; Early Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: 89Zr-NY008

Study type: Interventional

Funder types: Other

Identifiers

NCT05655676

LS2020001

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

89Zr-NY008

Experimental group

Treatment:

Drug: 89Zr-NY008