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Cancer Vaccine

64Cu-LLP2A Imaging for Blood Cancers

Phase < 1

Waitlist Available

Led By Farrokh Dehdashti, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy Volunteer: No illicit drug use or other inhaled drug use within the past year per self-reporting mechanisms

Hematological Malignancy: Clinical or pathologically defined MM or lymphoma including both newly diagnosed, relapsed or refractory disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from beginning of administration of 64cu-llpa2a through last phone call assessment (up to 7 days total)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medication in both healthy volunteers and patients with certain types of cancers to see if the medication works similarly to what was seen in a previous part of the study. The patients included

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the trial involves diagnostic imaging rather than treatment, side effects may include discomfort from the injection site or reactions related to the PET/CT scan procedure itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not used illicit or inhaled drugs in the past year.

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I have been diagnosed with multiple myeloma or lymphoma, whether new, relapsed, or resistant to treatment.

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I don't have claustrophobia or conditions that prevent me from undergoing imaging tests.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from beginning of administration of 64cu-llpa2a through last phone call assessment (up to 7 days total)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from beginning of administration of 64cu-llpa2a through last phone call assessment (up to 7 days total)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from beginning of administration of 64cu-llpa2a through last phone call assessment (up to 7 days total) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Organ dosimetry of participants

Safety and tolerability of new formulation of 64Cu-LLP2A as measured by number of participants with adverse events

Secondary study objectives

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

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Pilot/Cohort 1B: Dosimetry 64Cu-LLP2AExperimental Treatment2 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-LLP2AExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET/CT

2022

Completed Phase 3

~1300

0 / 4Eligibility criteria met