64Cu-LLP2A for Imaging Hematologic Malignancies

NCT06636175 | Recruiting Early Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: 202505198R42CA257797
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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; Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Keywords

PET; Imaging

Outcome Measures

Primary Outcomes (2)

• Organ dosimetry of participants

  Confirm organ dosimetry in healthy subjects and in patients with various hematological malignancies is consistent with prior formulation of 64Cu-LLP2A (all of Cohort 1 + up to 10 cohort 2 subjects). Average organ activity concentration will be measured, and decay corrected by utilizing regions of interest (ROIs) drawn around all organ visible on 64Cu-LLP2A images. Activity organ residence times will be calculated by numerical or analytical integration of the time-activity curves. Uptake/clearance functional fits of mono- or bi-exponential functions will be performed and analytical integration, accounted for physical decay, will be performed. The calculated residence times will be used with the program OLINDA/EXM for 64Cu and using the adult human (female and male) model to calculate the individual organ radiation dose, the whole-body dose and the effective dose.

  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

  Follow-up telephone call or in person visit to assess for self-reported adverse events associated with injection of 64Cu-LLP2A or PET/CT imaging. Additional chart review can be performed as needed.

  From beginning of administration of 64Cu-LLPA2A through last phone call assessment (up to 7 days total)

Secondary Outcomes (3)

• Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by overall quality of PET images

  Through completion of PET/CT scans (estimated to be up to 2 days)

• Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by bone marrow uptake

  Through completion of PET/CT scans (estimated to be up to 2 days)

• Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by tumor/background ratio

  Through completion of PET/CT scans (estimated to be up to 2 days)

Study Arms (2)

Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A

EXPERIMENTAL

\- 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)

Drug: 64Cu-LLP2A; Device: PET/CT

Cohort 2B: Quantitative 64Cu-LLP2A

EXPERIMENTAL

\- 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.

Drug: 64Cu-LLP2A; Device: PET/CT

Interventions

64Cu-LLP2A DRUG

64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)

Cohort 2B: Quantitative 64Cu-LLP2A; Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A

PET/CT DEVICE

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.

Cohort 2B: Quantitative 64Cu-LLP2A; Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases; Lymphoma, B-Cell; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Farrokh Dehdashti, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farrokh Dehdashti, M.D.

CONTACT

314-362-1474; dehdashtif@wustl.edu

Jennifer Frye, CNMT, CCRC

CONTACT

314-747-1604; fryej@wustl.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For Cohort 1B, 6 healthy volunteers and 6 patients with either multiple myeloma (MM) or lymphoma will be recruited (healthy volunteers will be split equally with 3 men and 3 women enrolled, all efforts will be made to keep the number of subjects with MM and lymphoma enrolled equal to Cohort 1B but it will not be a requirement).

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: February 26, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)