89Zr-labeled NY008 PET Imaging in Patients

NCT ID: NCT05655676

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-25

Study Completion Date

2023-05-31

Brief Summary

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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

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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89Zr-NY008

Group Type EXPERIMENTAL

89Zr-NY008

Intervention Type DRUG

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

Interventions

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89Zr-NY008

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Jiangnan University

OTHER

Sponsor Role lead

Responsible Party

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Chunjing Yu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunjing Yu

Role: CONTACT

Phone: 15312238622

Email: [email protected]

Facility Contacts

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Chunjing Yu

Role: primary

Other Identifiers

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LS2020001

Identifier Type: -

Identifier Source: org_study_id