Multiple MyelomaEarly Phase 1NCT05655676
89Zr-labeled NY008 PET Imaging in Patients
A Early Phase 1 study testing 89Zr-NY008 in people with Multiple Myeloma, run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial summary
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY008 PET Imaging in patients with multiple myeloma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- 89Zr-NY008
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2022to May 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years old, male or female;
- Patients diagnosed with relapsing or refractory multiple myeloma；
- LVEF≥50%；
- ECOG score 0~2；
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214000
Chunjing Yu, 15312238622, ycj_wxd1978@163.com
About this study
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
- Being tested
- 89Zr-NY008
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-NY008Drug
Patients will receive a tracer (5-10mg, IV) dose of 89Zr (2-3mCi) labelled NY008
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-NY008 | Experimental | Not described Receives: Drug: 89Zr-NY008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start25 May 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjing Yu, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655676
- Sponsor's protocol ID
- LS2020001
- Status last verified
- Dec 2022
- First submitted
- 5 Dec 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 89Zr-labeled NY008 PET Imaging in Patients
- ClinicalTrials.gov ID
- NCT05655676
- Acronym / sponsor ID
- LS2020001
- Conditions
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY008 PET Imaging in patients with multiple myeloma
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 89Zr-NY008 | Experimental | Drug: 89Zr-NY008 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 years old, male or female;
- Patients diagnosed with relapsing or refractory multiple myeloma；
- LVEF≥50%；
- ECOG score 0~2；
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-NY008Patients will receive a tracer (5-10mg, IV) dose of 89Zr (2-3mCi) labelled NY008 | Drug | 89Zr-NY008 |
Primary outcome
Evaluation of tissue distribution of 89Zr-NY008
Time frame: 7 days
Biodistribution of 89Zr-NY008 evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs will be reported.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 89Zr-NY008 in people with Multiple Myeloma, run by Affiliated Hospital of Jiangnan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunjing Yu (15312238622, ycj_wxd1978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of tissue distribution of 89Zr-NY008 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.