64Cu-LLP2A Imaging for Blood Cancers

Overseen By Jennifer Frye, CNMT, CCRC

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Washington University School of Medicine

Must not be taking: Illicit drugs

Disqualifiers: Pregnancy, Claustrophobia, Illicit drug use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

42 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have used illicit drugs or other inhaled drugs in the past year.

What data supports the effectiveness of the treatment 64Cu-LLP2A for blood cancers?

Research shows that copper-64 (64Cu) is effective in imaging various cancers, including prostate and bladder cancer, due to its ability to target cancer cells. This suggests that 64Cu-LLP2A might also be effective in imaging blood cancers, as it uses the same copper-64 component. ^{1 2 3 4 5}

Is 64Cu-LLP2A safe for use in humans?

64Cu-LLP2A has been tested in humans and showed a favorable safety profile, with no adverse effects observed in participants. It was well-tolerated in both animal and human studies, indicating it is generally safe for use in humans. ^{1 2 4 6 7}

How is the treatment 64Cu-LLP2A unique for blood cancers?

64Cu-LLP2A is unique because it targets a specific protein called VLA4, which is found on multiple myeloma cells and certain inflammatory cells, allowing for precise imaging of these cancer cells. This makes it different from other treatments that may not specifically target this protein, providing a more targeted approach to diagnosing and managing blood cancers. ^{1 2 5 6 8}

What is the purpose of this trial?

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.

Research Team

Farrokh Dehdashti, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for individuals with confirmed diagnoses of various blood cancers, including multiple myeloma and different types of lymphoma. It's also open to those who've had a bone marrow transplant but are suspected of cancer recurrence despite negative imaging results.

Inclusion Criteria

Healthy Volunteer: Able to give informed consent

Healthy Volunteer: Able to comprehend and willing to follow instructions for study procedures as called for by the protocol

Healthy Volunteer: No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging and Dosimetry

Participants undergo 64Cu-LLP2A-PET/CT imaging at multiple time points to calculate human dosimetry

2 days

Up to 3 visits (in-person)

Follow-up

Follow-up to assess for self-reported adverse events associated with injection of 64Cu-LLP2A or PET/CT imaging

7 days

1 visit (in-person or telephone)

Treatment Details

Interventions

• 64Cu-LLP2A

Trial Overview The study is testing a new formulation called 64Cu-LLP2A using PET/CT scans to see if it can help diagnose blood cancers like multiple myeloma and lymphomas more accurately in patients, including those post-bone marrow transplant.

Participant Groups

Group I: Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A Experimental Treatment 2 Interventions

- 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)

Group II: Cohort 2B: Quantitative 64Cu-LLP2A Experimental Treatment 2 Interventions

- 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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Findings from Research

Copper-64 (64Cu) is a promising PET/CT tracer for diagnosing various cancers, including prostate cancer and glioblastoma, due to its ability to target copper-avid tumors and its favorable nuclear properties for both imaging and therapy.

Studies indicate that 64CuCl2 is safe in terms of radiation and toxicology, making it a viable option for theragnostic applications in oncology, particularly for imaging and potentially treating cancers like hepatocellular carcinoma and malignant melanoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Copper in Cancer Imaging and Therapy: A New Theragnostic Agent. Capriotti, G., Piccardo, A., Giovannelli, E., et al.[2023]

Copper-64 chloride (64CuCl2) is a promising radiotracer for cancer imaging using PET, showing safety in humans and effective imaging for various cancers including prostate, bladder, and glioblastoma.

The dual emission of β+ and β- particles from 64CuCl2 suggests its potential not only for imaging but also for therapeutic applications in treating copper-avid tumors, especially with the development of the therapeutic copper-67 radionuclide for combined imaging and therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Advances in Cancer Imaging with 64CuCl2 PET/CT. Peng, F.[2023]

Copper-64 (64Cu) is a versatile radionuclide with a half-life of 12.7 hours, making it suitable for both PET imaging and targeted radiotherapy of cancer, allowing for the imaging of various biological molecules and nanoparticles.

The FDA has approved an investigational new drug application for 64Cu-ATSM, a hypoxia imaging agent, which sets the stage for a multicenter trial aimed at validating its clinical utility and potentially leading to routine clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Copper-64 radiopharmaceuticals for PET imaging of cancer: advances in preclinical and clinical research. Anderson, CJ., Ferdani, R.[2023]

The VLA4-targeted radiopharmaceutical 64Cu-LLP2A demonstrated a favorable safety profile in both animal and human studies, with no adverse effects observed in human participants after administration.

In human trials, 64Cu-LLP2A showed effective biodistribution and rapid clearance from the bloodstream, making it a promising imaging agent for multiple myeloma, with optimal imaging occurring 4-5 hours post-injection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Humans Evaluation of Safety and Dosimetry of 64Cu-LLP2A for PET Imaging. Laforest, R., Ghai, A., Fraum, TJ., et al.[2023]

In a study involving 23 patients with urological malignancies, the PET tracer copper-64(II)dichloride (64Cu(II)Cl2) demonstrated higher uptake in cancerous tissues compared to healthy tissues, indicating its potential effectiveness in detecting urological cancers.

64Cu(II)Cl2 was found to be safe, with no drug-related adverse effects reported, and showed high detection rates for prostate and bladder cancers (85.7%) and penile cancer (83.3%), suggesting it is a reliable imaging tool for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of the 64Cu(II)Cl2 PET/CT for Urological Malignancies: Phase IIa Clinical Study. Mascia, M., Villano, C., De Francesco, V., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Targeting Copper in Cancer Imaging and Therapy: A New Theragnostic Agent. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Recent Advances in Cancer Imaging with 64CuCl2 PET/CT. [2023]

3. England pubmed.ncbi.nlm.nih.gov

The emerging role of copper-64 radiopharmaceuticals as cancer theranostics. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Copper-64 radiopharmaceuticals for PET imaging of cancer: advances in preclinical and clinical research. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

64Cu2+ Ions as PET Probe: An Emerging Paradigm in Molecular Imaging of Cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

First-in-Humans Evaluation of Safety and Dosimetry of 64Cu-LLP2A for PET Imaging. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of the 64Cu(II)Cl2 PET/CT for Urological Malignancies: Phase IIa Clinical Study. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

64CuCl2 PET Imaging of 4T1-Related Allograft of Triple-Negative Breast Cancer in Mice. [2022]