64Cu-LLP2A Imaging for Blood Cancers

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging technique using 64Cu-LLP2A, a radiotracer, to better detect blood cancers like multiple myeloma and low-grade lymphoma. The goal is to determine if this method can accurately identify cancer recurrences in individuals who have undergone a bone marrow transplant. Participants will undergo PET/CT scans to help researchers evaluate the effectiveness of this new imaging. The trial seeks individuals with confirmed blood cancer diagnoses or those experiencing frequent recurrences after a bone marrow transplant. As an Early Phase 1 trial, this research aims to understand how this imaging technique functions in people, offering participants a chance to contribute to groundbreaking advancements in cancer detection.

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 prior data suggests that 64Cu-LLP2A is safe for imaging blood cancers?

Research shows that 64Cu-LLP2A is safe for people. In earlier studies, participants experienced no negative effects, confirming the treatment's safety. Participants handled the treatment well, with no health or lab problems reported. This suggests that 64Cu-LLP2A is likely safe for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 64Cu-LLP2A imaging technique because it offers a new way to visualize blood cancers. Unlike traditional imaging methods that may not always accurately highlight cancerous cells, this method uses a novel radioactive tracer, 64Cu-LLP2A, which specifically targets cancer cell markers, potentially providing clearer and more precise images. This could lead to better diagnosis and monitoring, helping doctors tailor treatments more effectively for individual patients.

What evidence suggests that 64Cu-LLP2A is effective for imaging blood cancers?

Research has shown that 64Cu-LLP2A holds promise for imaging blood cancers. It locates cancer cells, aiding in the detection of cancers such as multiple myeloma and lymphoma. Studies have demonstrated that it exits the bloodstream quickly, enhancing its safety profile. This trial includes two separate cohorts: one focusing on quantitative imaging and the other on dosimetry. The imaging agent clearly highlights cancer cells during scans, allowing doctors to see the cancer more distinctly. Although still in early stages, these findings suggest that 64Cu-LLP2A could become a valuable tool in diagnosing and tracking these blood cancers. ^{3 5 6 7 8}

Who Is on the Research Team?

Farrokh Dehdashti, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06636175

64Cu-LLP2A for Imaging Hematologic Malignancies A grouping of participants in a clinical study that is used for summarizing the data collected during the study. This grouping may be the same as or different ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9902845/

First-in-Humans Evaluation of Safety and Dosimetry ... Time–activity curves from human imaging data showed rapid tracer clearance from blood via the kidneys and bladder. The effective dose of 64Cu-LLP2A in ...

3. withpower.com withpower.com/trial/early-phase-1-lymphoma-10-2024-865d7

64Cu-LLP2A Imaging 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.

4. cancer.gov cancer.gov/clinicaltrials/NCI-2025-02222

64Cu-LLP2A PET/CT for the Imaging of Hematologic ... This early phase I trial studies whether 64Cu-LLP2A can be used during positron emission tomography (PET)/computed tomography (CT) for the imaging of ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03804424

NCT03804424 | 64Cu-LLP2A for Imaging Multiple Myeloma Early phase I evaluation of 64Cu-LLP2A for imaging multiple myeloma will generate imaging, safety and dosimetry data from PET/CT and MR studies of 64Cu-LLP2A.

6. jnm.snmjournals.org jnm.snmjournals.org/content/64/2/320

First-in-Humans Evaluation of Safety and Dosimetry of 64 ... The mean and SD of the administered mass of 64Cu-LLP2A was 9.52 ± 1.33 μg (range, 6.9–11.7 μg). There were no adverse or clinically detectable ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36008121/

First-in-Humans Evaluation of Safety and Dosimetry of 64Cu ... Conclusion: 64Cu-LLP2A exhibited a favorable dosimetry and safety profile for use in humans. Keywords: dosimetry; first-in-humans; ...

8. profiles.wustl.edu profiles.wustl.edu/en/publications/first-in-human-evaluation-of-safety-and-dosimetry-of-sup64supcu-l

First-in-Human Evaluation of Safety and Dosimetry of >64> ... No clinical or laboratory adverse events related to 64Cu-LLP2A were observed in the human participants. Conclusions: 64Cu-LLP2A exhibited a ...