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RECRUITING

NCT06636175

EARLY_PHASE1

64Cu-LLP2A for Imaging Hematologic Malignancies

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-02-26

Completion Date

2027-03-31

Last Updated

2025-07-31

Healthy Volunteers

Yes

Conditions

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

Interventions

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.

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States