64Cu-LLP2A for Imaging Hematologic Malignancies

July 29, 2025 updated by: Washington University School of Medicine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jennifer Frye, CNMT, CCRC
  • Phone Number: 314-747-1604
  • Email: fryej@wustl.edu

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Contact:
          • Jennifer Frye, CNMT, CCRC
          • Phone Number: 314-747-1604
          • Email: fryej@wustl.edu
        • Sub-Investigator:
          • Fei Wan, Ph.D.
        • Sub-Investigator:
          • Mark A Schroeder, M.D.
        • Sub-Investigator:
          • Armin Ghobadi, M.D.
        • Principal Investigator:
          • Farrokh Dehdashti, M.D.
        • Sub-Investigator:
          • Amanda Cashen, M.D.
        • Sub-Investigator:
          • Keith Stockerl-Goldstein, M.D.
        • Sub-Investigator:
          • Ravi Vij, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A

- 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)
Drug: 64Cu-LLP2A
64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)
Device: PET/CT
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.
Experimental: Cohort 2B: Quantitative 64Cu-LLP2A
- 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.
Drug: 64Cu-LLP2A
64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)
Device: PET/CT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Organ dosimetry of participants
Time Frame: Through 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.
Through completion of PET/CT scans (estimated to be up to 2 days)
Safety and tolerability of new formulation of 64Cu-LLP2A as measured by number of participants with adverse events
Time Frame: From 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.
From beginning of administration of 64Cu-LLPA2A through last phone call assessment (up to 7 days total)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by overall quality of PET images
Time Frame: Through completion of PET/CT scans (estimated to be up to 2 days)
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)
Through completion of PET/CT scans (estimated to be up to 2 days)
Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by bone marrow uptake
Time Frame: Through completion of PET/CT scans (estimated to be up to 2 days)
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
Through completion of PET/CT scans (estimated to be up to 2 days)
Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by tumor/background ratio
Time Frame: Through completion of PET/CT scans (estimated to be up to 2 days)
As measured by placing ROI and calculating SUVmax
Through completion of PET/CT scans (estimated to be up to 2 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Farrokh Dehdashti, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202505198
  • R42CA257797 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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