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89Zr-labeled NY008 PET Imaging in Patients

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
89Zr-NY008
Sponsored by
Affiliated Hospital of Jiangnan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Older than 18 years old, male or female; Patients diagnosed with relapsing or refractory multiple myeloma; LVEF≥50%; ECOG score 0~2; Exclusion Criteria: 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.

Sites / Locations

  • Affiliated Hospital of Jiangnan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

89Zr-NY008

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2022
Last Updated
December 15, 2022
Sponsor
Affiliated Hospital of Jiangnan University
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1. Study Identification

Unique Protocol Identification Number
NCT05655676
Brief Title
89Zr-labeled NY008 PET Imaging in Patients
Official Title
89Zr-labeled NY008 PET Imaging in Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Jiangnan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
89Zr-NY008
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
89Zr-NY008
Intervention Description
Patients will receive a tracer (5-10mg, IV) dose of 89Zr (2-3mCi) labelled NY008
Primary Outcome Measure Information:
Title
Evaluation of tissue distribution of 89Zr-NY008
Description
Biodistribution of 89Zr-NY008 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs will be reported.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older than 18 years old, male or female; Patients diagnosed with relapsing or refractory multiple myeloma; LVEF≥50%; ECOG score 0~2; Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunjing Yu
Phone
15312238622
Email
ycj_wxd1978@163.com
Facility Information:
Facility Name
Affiliated Hospital of Jiangnan University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunjing Yu
Phone
15312238622
Email
ycj_wxd1978@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

89Zr-labeled NY008 PET Imaging in Patients

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