89Zr-labeled NY008 PET Imaging in Patients

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05655676

Enrollment

Registered

2022-12-19

Start date

2022-05-25

Completion date

2023-05-31

Last updated

2022-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

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

Interventions

DRUG89Zr-NY008

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactChunjing Yu

ycj_wxd1978@163.com15312238622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026