Recruiting

Early Phase 1

64Cu-LLP2A64Cu-LLP2A for Imaging Hematologic Malignancies

Sponsor:

Washington University School of Medicine

Code:

NCT06636175

Conditions

Multiple Myeloma

Low-Grade Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

Lymphoplasmacytic Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

64Cu-LLP2A

PET/CT

Study Details

Brief 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

Study ID

NCT06636175

Start date

Mar 20, 2025

Status verified date

Jun, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A

\- Will be asked to undergo 64Cu-LLP2A-PET/CT imaging at up to three separate time points for purposes of calculating human dosimetry. Imaging time points will be dependent upon day of the week injection occurs:

Tuesday or Thursday injection: 0-60 minute multiple quick body scans + 120-180 min post injection body scan
Wednesday or Friday injection: 0-60 minute multiple quick body scans + 180-240 min post injection body scan
ALL PATIENTS: 15-28 hours post injection body scan on Wednesday (for Tuesday injection), Thursday (for Wednesday injection), Friday (for Thursday injection) or Saturday (for Friday injection)

experimental: Cohort 2B: Quantitative 64Cu-LLP2A

\- Will be asked to undergo dynamic PET/CT imaging centered over a known target lesion (as determined by other radiological imaging studies) beginning with 64Cu-LLP2A-PET/CT and continuing for a total of 60 minutes. An additional vertex to upper thigh body scan will be obtained between 60- and 180-minutes post injection or at the optimal imaging time point that was derived from cohort 1B.

Interventions

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)

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.

Primary outcome measure

Organ dosimetry of participants [ Time Frame: Through completion of PET/CT scans (estimated to be up to 2 days) ]
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) ]

Central Contacts and Locations

Central contacts

Farrokh Dehdashti, M.D.

314-362-1474 dehdashtif@wustl.edu

Jennifer Frye, CNMT, CCRC

314-747-1604 fryej@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Farrokh Dehdashti, M.D.

314-362-1474 dehdashtif@wustl.edu

Jennifer Frye, CNMT, CCRC

314-747-1604 fryej@wustl.edu

Principal Investigator:

Farrokh Dehdashti, M.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

PET
Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-06-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.