89Zr-labeled NY008 PET Imaging in Patients

NCT05655676 | Unknown Early Phase 1

• 1 other identifier: LS2020001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Evaluation of tissue distribution of 89Zr-NY008

  Biodistribution of 89Zr-NY008 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs will be reported.

  7 days

Study Arms (1)

89Zr-NY008

EXPERIMENTAL

Drug: 89Zr-NY008

Interventions

89Zr-NY008 DRUG

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

89Zr-NY008

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years old, male or female;
• Patients diagnosed with relapsing or refractory multiple myeloma；
• LVEF≥50%；
• ECOG score 0\~2；

You may not qualify if:

• Life expectancy of less than 3 months;
• Participated in other clinical research within 1 month;
• Recovery from major trauma (including surgery) within 28 days prior to study treatment;
• Patients with systemic or locally severe infections, or other serious coexisting diseases;
• Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
• Patients with autoimmune diseases, including rheumatoid arthritis;
• Inadequate control of arrhythmias, including atrial fibrillation;
• Uncontrolled hypertension;
• Patients with allergies or allergies to any component of the imaging agent or antibody;
• Patients who cannot undergo PET/CT imaging scan;
• Syphilis, HBV, HCV, or HIV positive subjects;
• Male and female subjects of reproductive age cannot take effective contraceptive measures;
• Pregnant or lactating women;
• Patients with a history of mental illness or related conditions;
• Other subjects considered unsuitable by researchers.

Sponsors & Collaborators

• Affiliated Hospital of Jiangnan University: lead

Study Sites (1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Chunjing Yu

CONTACT

15312238622; ycj_wxd1978@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 19, 2022
• Study Start: May 25, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)