Early Phase I Study of 64Cu-LLP2A PETCT Imaging in Adults with Blood Cancers or Healthy Volunteers

What this Trial Is About

Researchers are evaluating a new formulation of 64Cu-LLP2A, a drug used for PETCT imaging, in both healthy volunteers and patients with blood cancers such as multiple myeloma and low-grade lymphoma. This early phase study aims to confirm that the new formulation provides comparable human dosimetry to the previous formulation while expanding the patient population to include those with confirmed diagnoses or those who have undergone bone marrow transplant with suspected disease recurrence. Participants will receive the 64Cu-LLP2A drug followed by PETCT imaging at up to three different time points depending on the day of injection. Imaging includes multiple quick body scans shortly after injection, scans at 120-180 or 180-240 minutes post-injection, and a delayed scan 15-28 hours later. Some participants will also undergo a dynamic PETCT scan focused on a known target lesion for 60 minutes, followed by an additional whole-body scan. During the study, participants will be monitored for organ dosimetry and safety through adverse event tracking up to 7 days after administration. The quality of PET images will be assessed based on overall image quality, bone marrow uptake, and tumor-to-background ratios. Participants must lie still within the scanner for up to 75 minutes during imaging sessions. The study is expected to complete by March 2027.

64Cu-LLP2A for Imaging Hematologic Malignancies