NCT06636175TerminatedEarly phase 1
64Cu-LLP2A for Imaging Hematologic Malignancies
Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 8 Oct 2024
- Start date
- 20 Mar 2025
- Primary completion date
- 28 Aug 2026
- Lead sponsor
- Washington University School of Medicine
- NCT number
- NCT06636175
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.