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Multiple MyelomaEarly Phase 1NCT06636175

64Cu-LLP2A for Imaging Hematologic Malignancies

A Early Phase 1 study testing 64Cu-LLP2A and PET/CT in people with Multiple Myeloma and Low-Grade Lymphoma, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
64Cu-LLP2A and PET/CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
20 Mar 2025to 28 Aug 2026
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B

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.

Being tested
64Cu-LLP2A, PET/CT
Keywords
PET, Imaging
Medical subject headings
Multiple Myeloma, Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 64Cu-LLP2ADrug

    64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)

  • PET/CTDevice

    The results of 64Cu-LLP2A-PET/CT will not be provided to the patient or the treating oncologist/surgeon unless, in the judgment of the principal investigator, the images demonstrate an unsuspected abnormality that may warrant further evaluation.

Study groups in NCT06636175
Study groupRoleWhat they receive
Pilot/Cohort 1B: Dosimetry 64Cu-LLP2AExperimental- Will be asked to undergo 64Cu-LLP2A-PET/CT imaging at up to three separate time points for purposes of calculating human dosimetry. Imaging time points will be dependent upon day of the week injection occurs: * Tuesday or Thursday injection: 0-60 minute multiple quick body scans + 120-180 min post injection body scan * Wednesday or Friday injection: 0-60 minute multiple quick body scans + 180-240 min post injection body scan * ALL PATIENTS: 15-28 hours post injection body scan on Wednesday (for Tuesday injection), Thursday (for Wednesday injection), Friday (for Thursday injection) or Saturday (for Friday injection)
Receives: Drug: 64Cu-LLP2A; Device: PET/CT
Cohort 2B: Quantitative 64Cu-LLP2AExperimental- Will be asked to undergo dynamic PET/CT imaging centered over a known target lesion (as determined by other radiological imaging studies) beginning with 64Cu-LLP2A-PET/CT and continuing for a total of 60 minutes. An additional vertex to upper thigh body scan will be obtained between 60- and 180-minutes post injection or at the optimal imaging time point that was derived from cohort 1B.
Receives: Drug: 64Cu-LLP2A; Device: PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Organ dosimetry of participants

    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.

    Measured: 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

    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.

    Measured: From beginning of administration of 64Cu-LLPA2A through last phone call assessment (up to 7 days total)

Secondary outcomes (3)

  1. Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by overall quality of PET images

    Overall, PET image quality will be graded visually (using 4-point scale with 1 being the worst and poor quality, not acceptable for diagnostic interpretation and 4 being good image quality, similar to routine clinical studies)

    Measured: Through completion of PET/CT scans (estimated to be up to 2 days)

  2. Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by bone marrow uptake

    As measured by placing ROI and calculating SUVmax where SUVmax is a mathematical measurement of tumor burden seen on images and calculated by the following equation SUVmax= r / (a'/w) where r= radioactivity concentration in tumor (kBq/ml) as measured by the PET scanner within a defined region of interest, a'=the decay corrected amount of injected 64Cu-LLP2A and w= weight of the patient in grams

    Measured: Through completion of PET/CT scans (estimated to be up to 2 days)

  3. Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by tumor/background ratio

    As measured by placing ROI and calculating SUVmax

    Measured: Through completion of PET/CT scans (estimated to be up to 2 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2024
  2. Study start20 Mar 2025
  3. Primary completion28 Aug 2026
  4. Study completion28 Aug 2026

Why it stopped: Loss of further funding

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
For Cohort 1B, 6 healthy volunteers and 6 patients with either multiple myeloma (MM) or lymphoma will be recruited (healthy volunteers will be split equally with 3 men and 3 women enrolled, all efforts will be made to keep the number of subjects with MM and lymphoma enrolled equal to Cohort 1B but it will not be a requirement).
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06636175
Sponsor's protocol ID
202505198
Other IDs
R42CA257797
Status last verified
Oct 2026
First submitted
8 Oct 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 64Cu-LLP2A and PET/CT in people with Multiple Myeloma and Low-Grade Lymphoma, run by Washington University School of Medicine at 1 site in United States.

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 15 inclusion and 0 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: stopped early, as of the sponsor's last update on 16 Oct 2026. 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 United States. 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?

The study was stopped early (reason given: Loss of further funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Organ dosimetry of participants (time frame: Through completion of PET/CT scans (estimated to be up to 2 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06636175.

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 16 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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