Acute MyocarditisPhase 1NCT07481136
64Cu-GRIP B in Patients With Acute Myocarditis
A Phase 1 study testing 64Cu-GRIP B is a radiolabeled peptide tracer, a copper-64 isotope bound to a peptide designed to target extracellular Granzyme B in people with Acute Myocarditis, run by Javid Moslehi, MD at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Myocarditis
- What is being tested?
- 64Cu-GRIP B is a radiolabeled peptide tracer, a copper-64 isotope bound to a peptide designed to target extracellular Granzyme B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2031
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically or cytologically confirmed myocarditis in accordance with the Dallas Criteria
- The subject is able and willing to comply with study procedures and provide signed and dated informed consent
- Age ≥18 years
- Demonstrates adequate organ function as defined below:
- Adequate bone marrow function:
- absolute neutrophil count ≥1,500/mcL platelets ≥100,000/mcL
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- Adequate hepatic function:
- total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits AST(SGOT) ≤3 X institutional upper limit of normal ALT(SGPT) ≤3 X institutional upper limit of normal
- Adequate renal function:
- creatinine ≤ 1.5 x within institutional upper limit of normal OR creatinine clearance GFR ≥ 60 mL/min/1.73 m2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2
- Ability to understand and the willingness to sign a written informed consent document.
- Human immunodeficiency virus (HIV)-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- The effects of 64Cu-GRIP B on the developing human fetus are unknown. For this reason and because a diagnostic PET radiotracer that is used in this trial is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception for the duration of study participation and for 2 weeks after last administration of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 2 weeks after administration of study drug.
Who cannot join
- Has received systemic anticancer therapies within 3 weeks of first dose, radiation within 2 weeks, antibody therapy within 4 weeks. Concomitant administration of LHRH analogues for prostate cancer and somatostatin analogues for neuroendocrine tumors are allowed as per standard of care.
- Has not recovered from adverse events due to prior anti-cancer therapy to ≤ grade 1 or baseline (other than alopecia).
- Is currently receiving any other investigational agents.
- Has participated in a study of an investigational product and received study treatment or used an investigational device within 6 weeks of the first dose of study drug.
- Any other cardiac condition that may result in non-specific findings, including recent (within 6 months) Acute Coronary Syndrome or Type II NSTEMI. Participants with a recent viral infection, such as Influenza A, will also be excluded.
- Hypersensitivity to PET radiotracers or any of its excipients.
- Pregnant women are excluded from this study because 64Cu-GRIP B is a PET radiotracer with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to assessment of the mother with 64Cu-GRIP B, breastfeeding should be discontinued if the mother is treated with 64Cu-GRIP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
Sofia Tasca, BS, 415-514-6559, sofia.tasca@ucsf.edu
Javid Moslehi, MD
About this study
Official title: A Phase I PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in Patients With Acute Myocarditis
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.
- Conditions
- Acute Myocarditis
- Being tested
- 64Cu-GRIP B is a radiolabeled peptide tracer, a copper-64 isotope bound to a peptide designed to target extracellular Granzyme B
- Keywords
- Acute Myocarditis, Diagnosis, PET Imaging
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-GRIP B is a radiolabeled peptide tracer, a copper-64 isotope bound to a peptide designed to target extracellular Granzyme BDrug
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. This study is the first to evaluate the efficacy of 64Cu-GRIP B PET in detecting acute myocarditis. Notably, 64Cu-GRIP is currently being investigated in the setting of cancer in NCT05888532 and has been well tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: participants with acute myocarditis (5 males, 5 females) | Experimental | 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. Receives: Drug: 64Cu-GRIP B is a radiolabeled peptide tracer, a copper-64 isotope bound to a peptide designed to target extracellular Granzyme B |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of detecting affected cardiac tissue in patients with acute myocarditis
- SUVmax of at least 1.5-fold above adjacent background at 4 hours post injection
Measured: From first dose administration through the safety follow-up at Day 70
To descriptively compare the number of areas of cardiac inflammation detected on ⁶⁴Cu-GRIP B PET imaging with those observed in a separate ⁶⁴Cu-GRIP B PET study of patients with cancer
- Compare the uptake in acute myocarditis cohort compared to the cohort from NCT05888532 that are undergoing the same PET imaging protocol but have no signs of myocarditis.
Measured: From first dose administration through the safety follow-up at Day 70
Secondary outcomes (3)
Association Between 64Cu-GRIP B PET Uptake and Blood-Based Immune Parameters
Association between myocardial uptake of 64Cu-GRIP B measured by PET and blood-based immune biomarkers (e.g., circulating cytokine levels) in participants with acute myocarditis
Measured: From first dose administration through the safety follow-up at Day 70
Association Between 64Cu-GRIP B PET Uptake and Circulating Immune Cell Populations
Association between myocardial uptake of 64Cu-GRIP B measured by PET and circulating immune cell populations measured in peripheral blood in participants with acute myocarditis
Measured: From first dose administration through the safety follow-up at Day 70
Association Between 64Cu-GRIP B PET Uptake and Tissue-Based Immune Parameters
Association between myocardial uptake of 64Cu-GRIP B measured by PET and immune parameters measured in myocardial tissue samples in participants with acute myocarditis
Measured: From first dose administration through the safety follow-up at Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute MyocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Javid Moslehi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Javid Moslehi, MD, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481136
- Sponsor's protocol ID
- 25-45647
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fankhauser RG, Johnson DB, Moslehi JJ, Balko JM. Preclinical mouse models of immune checkpoint inhibitor-associated myocarditis. Nat Cardiovasc Res. 2025 May;4(5):526-538. doi: 10.1038/s44161-025-00640-2. Epub 2025 May 7.
PubMed 40335724Song EJ, Joachimbauer A, Tasca S, Baylis R, Schmidt D, Ludewig B, Moslehi JJ. T cells in acute and chronic myocarditis: from diagnosis to treatment. Eur Heart J. 2026 May 18;47(19):2255-2270. doi: 10.1093/eurheartj/ehaf1080.
PubMed 41605248Ehlerding EB, England CG, McNeel DG, Cai W. Molecular Imaging of Immunotherapy Targets in Cancer. J Nucl Med. 2016 Oct;57(10):1487-1492. doi: 10.2967/jnumed.116.177493. Epub 2016 Jul 28.
PubMed 27469363Zhao N, Bardine C, Lourenco AL, Wang YH, Huang Y, Cleary SJ, Wilson DM, Oh DY, Fong L, Looney MR, Evans MJ, Craik CS. In Vivo Measurement of Granzyme Proteolysis from Activated Immune Cells with PET. ACS Cent Sci. 2021 Oct 27;7(10):1638-1649. doi: 10.1021/acscentsci.1c00529. Epub 2021 Sep 2.
PubMed 34729407Zhang L, Zlotoff DA, Awadalla M, Mahmood SS, Nohria A, Hassan MZO, Thuny F, Zubiri L, Chen CL, Sullivan RJ, Alvi RM, Rokicki A, Murphy SP, Jones-O'Connor M, Heinzerling LM, Barac A, Forrestal BJ, Yang EH, Gupta D, Kirchberger MC, Shah SP, Rizvi MA, Sahni G, Mandawat A, Mahmoudi M, Ganatra S, Ederhy S, Zatarain-Nicolas E, Groarke JD, Tocchetti CG, Lyon AR, Thavendiranathan P, Cohen JV, Reynolds KL, Fradley MG, Neilan TG. Major Adverse Cardiovascular Events and the Timing and Dose of Corticosteroids in Immune Checkpoint Inhibitor-Associated Myocarditis. Circulation. 2020 Jun 16;141(24):2031-2034. doi: 10.1161/CIRCULATIONAHA.119.044703. Epub 2020 Jun 15. No abstract available.
PubMed 32539614Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072.
PubMed 30545455Ammirati E, Moslehi JJ. Diagnosis and Treatment of Acute Myocarditis: A Review. JAMA. 2023 Apr 4;329(13):1098-1113. doi: 10.1001/jama.2023.3371.
PubMed 37014337