64Cu-GRIP B for Myocarditis

Overseen By Javid J Moslehi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Javid Moslehi, MD

Must not be taking: Anticancer therapies, Investigational agents

Disqualifiers: Acute coronary syndrome, Type II NSTEMI, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

The proposed patient study represents the first-ever acute myocarditis patient imaging study with 64Cu-GRIP B PET. The tracer is designed to detect extracellular granzyme B as it is secreted by activated cytotoxic T lymphocytes in the cardiomyocyte inflammatory microenvironment, highlighting areas of CD8 T cell activity leading to cardiomyocyte damage. Myocarditis is characterized pathologically by myocardial infiltration of T cells and macrophages with presence of cardiomyocyte death - the proposed tracer tests for both the accumulation of CD8 T cells and their cytotoxic activity, which will hopefully significantly improve diagnostic certainty. The study population is focused on patients with acute myocarditis to assess the specificity and sensitivity of 64Cu-GRIP B to detect myocarditis. In future studies, 64Cu-GRIP B PET may also serve as a biomarker to monitor early response to immunomodulatory therapies to treat acute myocarditis.

Each year at UCSF, the investigators encounter about 20 patients with acute myocarditis. These patients often present with non-specific cardiac symptoms with some evidence of cardiac injury (abnormal electrocardiogram or elevation in cardiac biomarkers such as troponin). Rarely is the diagnosis clear and often numerous additional clinical studies are necessary to rule out other common causes of cardiac injury like myocardial infarction. Patients identified with acute myocarditis by the investigators will receive standard clinical testing as appropriate and will also be consented to participate in a PET study with 64Cu-GRIP B. Over the course of this proposal, the investigators expect to enroll 10 patients who are being evaluated for acute myocarditis determined by current standard of care diagnostic modalities. The investigators will perform this feasibility assessment in parallel to the usual clinical care.

Are You a Good Fit for This Trial?

Inclusion Criteria

My bone marrow, liver, and kidneys are working well.

Ability to understand and the willingness to sign a written informed consent document

I am 18 years old or older.

Exclusion Criteria

I do not have recent serious heart problems or a recent viral infection.

Pregnant women and breastfeeding women treated with 64Cu-GRIP B are excluded

I have recently received cancer treatments like chemotherapy, radiation, or antibody therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 64Cu-GRIP B intravenously and undergo whole body PET imaging 4 hours post-injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including association between PET uptake and immune parameters

10 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• 64Cu-GRIP B

How Is the Trial Designed?

Group I: Cohort A: participants with acute myocarditis (5 males, 5 females) Experimental Treatment 1 Intervention

Participants will undergo whole body PET imaging 4 hours (+/- 1 hour) following 64Cu-GRIP B injections. 64Cu-GRIP B will be administered on an outpatient basis. It will be administered intravenously prior to PET imaging.

Who Is Running the Clinical Trial?

Javid Moslehi, MD

Lead Sponsor