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64Cu-LLP2A Imaging for Blood Cancers

This study is testing a new version of a special imaging agent called 64Cu-LLP2A. This agent is used with a PET/CT scan (a type of imaging that shows how organs and tissues are working) to help doctors see certain blood cancers like multiple myeloma and low-grade lymphoma. The main goals are to check how much of the imaging agent healthy volunteers are exposed to and to make sure the new version is safe and well-tolerated. The study will also look at how this imaging agent works in patients with these cancers, including those who have had a bone marrow transplant and might have a recurrence. This study aims to enroll 42 participants.

Study design
This is an interventional study that plans to enroll 42 participants, including healthy volunteers and patients with specific blood cancers.
What's involved
You would receive an administration of 64Cu-LLP2A and undergo PET/CT scans, which could take up to 75 minutes. You would also have follow-up assessments for up to 7 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and tolerability from the beginning of 64Cu-LLPA2A administration through a last phone call assessment, up to 7 days total.

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NCT06636175

64Cu-LLP2A for Imaging Hematologic Malignancies

Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnostic
Washington University School of Medicine
~42 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:64Cu-LLP2APET/CT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Organ dosimetry of participants
Measured over Through completion of PET/CT scans (estimated to be up to 2 days)
+1 more outcome measured

Conditions

Multiple Myeloma
Low-Grade Lymphoma
Follicular Lymphoma
Marginal Zone Lymphoma
Lymphoplasmacytic Lymphoma
Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia

Explore related trials

Chronic Lymphocytic LeukemiaFollicular LymphomaHematologic NeoplasmLymphoplasmacytic LymphomaMarginal Zone LymphomaMultiple MyelomaSmall Lymphocytic Lymphoma

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Farrokh Dehdashti, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Farrokh Dehdashti, M.D.
[email protected]
314-362-1474
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult 18 years of age or older
Able to give informed consent.
Able to comprehend and willing to follow instructions for study procedures as called for by the protocol
Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
No illicit drug use or other inhaled drug use (including pharmacologic agents and illicit drugs) within the past year per self-reporting mechanisms.
No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions.
Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative.
Clinical or pathologically defined MM or lymphoma including both newly diagnosed, relapsed or refractory disease:
Multiple Myeloma defined in accordance with the International Myeloma Working Group criteria
Low-grade lymphoma, including the following subtypes: follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia
Adult 18 years of age or older and able to provide informed consent
Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions
Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative
Patients participating in imaging or therapeutic trials with investigational agents are eligible to participate

What this trial measures

  • Organ dosimetry of participantsThrough completion of PET/CT scans (estimated to be up to 2 days)

    Confirm organ dosimetry in healthy subjects and in patients with various hematological malignancies is consistent with prior formulation of 64Cu-LLP2A (all of Cohort 1 + up to 10 cohort 2 subjects). Average organ activity concentration will be measured, and decay corrected by utilizing regions of interest (ROIs) drawn around all organ visible on 64Cu-LLP2A images. Activity organ residence times will be calculated by numerical or analytical integration of the time-activity curves. Uptake/clearance functional fits of mono- or bi-exponential functions will be performed and analytical integration, accounted for physical decay, will be performed. The calculated residence times will be used with the program OLINDA/EXM for 64Cu and using the adult human (female and male) model to calculate the individual organ radiation dose, the whole-body dose and the effective dose.

  • Safety and tolerability of new formulation of 64Cu-LLP2A as measured by number of participants with adverse eventsFrom beginning of administration of 64Cu-LLPA2A through last phone call assessment (up to 7 days total)

    Follow-up telephone call or in person visit to assess for self-reported adverse events associated with injection of 64Cu-LLP2A or PET/CT imaging. Additional chart review can be performed as needed.