Recruiting

Phase 1

\[89Zr\]DFO-YS5Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma

Sponsor:

Robert Flavell, MD, PhD

Code:

NCT05892393

Conditions

Multiple Myeloma

Plasma Cell Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Zirconium Zr 89-DFO-YS5

Positron Emission Tomography / Computed Tomography (PET/CT)

Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI)

Fludeoxyglucose F-18

Study Details

Brief summary:

This phase I trial tests the safety of \[89Zr\]DFO-YS5 positron emission tomography (PET) imaging and how well it works to detect CD46 positive cancer cells in patients with multiple myeloma. \[89Zr\]DFO-YS5 is an imaging agent called a radiopharmaceutical tracer. A radiopharmaceutical tracer uses a small amount of radioactive material that is injected into a vein to help image different areas of the body. \[89Zr\]DFO-YS5 targets a specialized protein called CD46, which is in certain multiple myeloma cancer cells, and \[89Zr\]DFO-YS5 PET scans may improve detection of multiple myeloma.

Conditions

Multiple Myeloma

Plasma Cell Myeloma

Study ID

NCT05892393

Start date

Jun 16, 2023

Status verified date

Jun, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants must have histologically or cytologically confirmed multiple myeloma by International Myeloma Working Group (IMWG) diagnostic criteria
At least one positive myelomatous lesion found on 18F-FDG PET/CT or PET/MRI. A positive lesion is defined as uptake greater than liver on FDG PET, based on the Italian myeloma criteria for PET use (IMPeTUs) criteria
Age >= 18 years
Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) =< 3 X ULN
Alanine aminotransferase (ALT) =< 3 X ULN
Creatinine clearance >= 30 mL/min, calculated using the Cockcroft-Gault equation or serum creatinine <= 1.5x the institutional upper limit of normal.
Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

Any condition that, in the opinion of the principal investigator, would impair the participants' ability to comply with study procedures or interfere with the safety of the investigational regimen
Individuals who are pregnant or breastfeeding/chestfeeding.
\- Breast-feeding/chest-feeding should be discontinued before administration of \[89ZR\]DFO-YS5.
Females of childbearing potential must have a negative urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours prior to administration of \[89ZR\]-DFO-YS5.
\- If the urine pregnancy test is positive or equivocal, a confirmatory serum pregnancy test is required. In such cases, the individual must be excluded from participation if the serum pregnancy result is positive.
\- A female is considered to be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), unless it is documented that the individual meets either of the following two criteria: (1) has reached a postmenopausal state ( >= 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).
Individuals who are pregnant or breastfeeding/chestfeeding are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to treatment of the study participant with \[89ZR\]-DFO-YS5

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort A ([89Zr]DFO-YS5, single scan

Participants receive \[89Zr\]DFO-YS5 IV and undergo a single PET/CT or PET/MRI scan 5-7 days post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1

experimental: Cohort B ([89Zr]DFO-YS5, multiple scans

Participants receive \[89Zr\]DFO-YS5 IV and undergo four PET/CT or PET/MRI scans on days 1, 2, 3-4, and 5-7 post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1

Interventions

Zirconium Zr 89-DFO-YS5

Given IV

Positron Emission Tomography / Computed Tomography (PET/CT)

Positron emission tomography-computed tomography is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography scanner and an x-ray computed tomography scanner, to acquire sequential images from both devices in the same session, which are combined into a single superposed image

Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI)

Positron emission tomography-magnetic resonance imaging is a hybrid imaging technology that incorporates magnetic resonance imaging soft tissue morphological imaging and positron emission tomography functional imaging.

Fludeoxyglucose F-18

Given IV

Primary outcome measure

Sensitivity of metastatic lesion [ Time Frame: Up to 1 week ]
Median maximum standardized uptake value (SUVmax) [ Time Frame: Up to 1 week ]
Median Standardized Uptake Value averaged across lesions (SUVmax-avg) [ Time Frame: Up to 1 week ]

Central Contacts and Locations

Central contacts

Maya Aslam

(415) 514-8987 Maya.Aslam@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Maya Aslam

(415) 514-8987 Maya.Aslam@ucsf.edu

877-827-3222 cancertrials@ucsf.edu

Principal Investigator:

Robert Flavell, MD, PhD

More Information

Sponsor

Robert Flavell, MD, PhD

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Robert Flavell, MD, PhD on 2026-06-15.