NCT05892393 Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma
| NCT ID | NCT05892393 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Robert Flavell, MD, PhD |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-06-16 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-06-16 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Robert Flavell, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05892393 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05892393 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05892393 currently recruiting?
Yes, NCT05892393 is actively recruiting participants. Contact the research team at Maya.Aslam@ucsf.edu for enrollment information.
Where is the NCT05892393 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05892393 clinical trial?
NCT05892393 is sponsored by Robert Flavell, MD, PhD. The principal investigator is Robert Flavell, MD, PhD at University of California, San Francisco. The trial plans to enroll 20 participants.