Abatacept for Myocarditis from Cancer Immunotherapy
This study is testing if a drug called abatacept can help patients who develop a serious heart condition called myocarditis (inflammation of the heart muscle) after receiving immune checkpoint inhibitors (a type of cancer treatment). Myocarditis is an uncommon side effect of these cancer drugs, and even with standard treatments like steroids, it can be very dangerous. Researchers want to see if abatacept, which works by blocking certain immune cells, can reduce major heart problems like heart attack, heart failure, or sudden cardiac arrest. You may be able to join if you are 18 or older and have myocarditis caused by immune checkpoint inhibitors. The study aims to enroll 390 participants and will measure major heart problems over 6 months.
- Study design
- This is a randomized study comparing abatacept to a placebo, along with standard care. It plans to include 390 participants.
- What's involved
- You would receive up to four infusions of abatacept or a placebo. The study will measure major adverse cardiac events at 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Major heart problems will be measured at 6 months after starting the study.
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NCT05335928
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Recruiting
PHASE3Ages 18+InterventionalTreatmentMassachusetts General HospitalInvestigator-initiated
~390 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Abatacept plusPlacebo
At a glance
Recruiting sites
30 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major adverse cardiac events
Measured over 6 months
Conditions
Where it's being run
31 sites across 23 statesMassachusetts4
Pennsylvania3
California2
New York2
Texas2
District of Columbia1
Florida1
Illinois1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Total white blood cell (WBC) count \>2,500/μl
Absolute neutrophil count (ANC) \>1,500/μL
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \<20 times the upper limit of the institutional normal ranges; 9. Women of childbearing potential (i.e., not postmenopausal, or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test prior to randomization. Participating women of childbearing potential must be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug. Participating men must also be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug; and 10. Must be willing and able to abide by all study requirements and restrictions.
Exclusion
A sudden cardiac arrest
Cardiogenic shock as defined. A significant bradyarrhythmia (Mobitz type II second degree atrioventricular block or third degree (complete) atrio-ventricular (AV) block, for which an intervention with a temporary or permanent pacemaker is completed or recommended).
A significant tachyarrhythmia (ventricular fibrillation of any duration or sustained ventricular tachycardia (\>30 seconds, \>120 beats per minute); or a ventricular tachyarrhythmia requiring intervention. 2. Recent (≤2 month) exposure to abatacept or belatacept. 3. Concurrent or recent (≤2 month) use of the following non-corticosteroid immunosuppressive therapies prior to randomization: mycophenolate, JAK STAT inhibitors (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib), tacrolimus, anti-thymocyte globulin, alemtuzumab, infliximab, and plasma exchange. The use of intravenous immunoglobulin is permitted prior to randomization and during study treatment. 4. Currently enrolled in another interventional study utilizing systemic agents for the management of ICI-related toxicities. 5. Female who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 90 days after the last dose of study drug. 6. Male who is considering fathering a child or donating sperm during the study or for approximately 30 days after the last dose of study drug. 7. Any active, chronic, or recurrent viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study. These may include hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a single episode) herpes zoster, and disseminated (even a single episode) herpes simplex. Active HBV and HCV are defined as: HBV: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for Hepatitis B core antibody (HBc Ab) positive (+) participants; HCV: HCV ribonucleic acid (RNA) detectable in any participant with anti-HCV antibody (HCV Ab). Patients with active Covid-19 infection will be excluded. This is defined as the period of ongoing symptoms in the setting of a positive Covid-19 test, or until 10 days after symptom onset and after resolution of fever for at least 24 hours, without the use of fever-reducing medications. 8. Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections; 9. Receipt of any live vaccine within four weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 90 days after the last dose of IV study drug. 10. Any medical condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the Investigator, increase the risk of the participant by participating in the study. 11. Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.
What this trial measures
- Major adverse cardiac events6 months
The rates of a composite of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrhythmias, significant bradyarrhythmias, or incident heart failure.