64Cu-LLP2A for Imaging Hematologic Malignancies (NCT06636175) | Clinical Trial Compass
RecruitingEarly Phase 1
64Cu-LLP2A for Imaging Hematologic Malignancies
United States42 participantsStarted 2025-03-20
Plain-language summary
This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Additionally, the new formulation will be studied utilizing an expanded patient population to include patients with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma patients who are status post bone marrow transplant (BMT) with negative imaging and suspected recurrence.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Healthy Volunteer:
* 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.
Inclusion Criteria Hematological Malignancy:
* 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 inform…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an early Phase 1 trial that's primarily measuring organ dosimetry and safety of a new formulation of 64Cu-LLP2A, does that mean the main goal right now is to understand radiation exposure and whether it's safe — not yet to prove it improves my treatment outcomes?
2The trial uses a radioactive tracer called 64Cu-LLP2A for imaging — can you explain what that actually involves for me physically, like how it's given, how long the radioactive material stays in my body, and what the imaging process looks like day to day?
3My diagnosis falls within the conditions this trial covers — but given that it includes everything from Multiple Myeloma to Chronic Lymphocytic Leukemia, would you say this imaging approach is particularly relevant to my specific type, or is it worth waiting to see more targeted data?
4Because this is such an early-phase study focused on safety and dosimetry, is there a risk that participating could delay me starting or continuing standard treatment, and how would you weigh that tradeoff given where I am right now?
5If adverse events do occur with this new formulation of 64Cu-LLP2A, what kinds of side effects are doctors watching for most closely, and what would the plan be to manage them if they happened to me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Organ dosimetry of participants
Timeframe: Through completion of PET/CT scans (estimated to be up to 2 days)
2
Safety and tolerability of new formulation of 64Cu-LLP2A as measured by number of participants with adverse events
Timeframe: From beginning of administration of 64Cu-LLPA2A through last phone call assessment (up to 7 days total)