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NCT Number: NCT06636175

64Cu-LLP2A for Imaging Hematologic Malignancies

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia Disease Attributes Follicular Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Low-Grade Lymphoma Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoplasmacytic Lymphoma Lymphoproliferative Disorders Marginal Zone Lymphoma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Small Lymphocytic Lymphoma Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

64Cu-LLP2A

Drug

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

PET/CT

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2024
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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