NCT06636175

64Cu-LLP2A for Imaging Hematologic Malignancies

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-26
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2024-10-10
• Last updated: 2025-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study