Could a targeted immune blocker tame a deadly heart side effect of cancer drugs?
NCT ID NCT05195645
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether the drug abatacept can safely and effectively treat severe heart inflammation (myocarditis) caused by immune checkpoint inhibitors, a type of cancer immunotherapy. The study enrolls adults with any cancer who develop this rare but often fatal heart complication. Researchers will test three different doses of abatacept to find the lowest dose that adequately blocks a specific immune signal, aiming to calm the overactive immune response without harming the anti-cancer effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- abatacept (also known as Orencia), given by intravenous injection
- What this could lead to
- If successful, this could provide a targeted treatment for a rare but often fatal heart complication from cancer immunotherapy, potentially saving lives.
- What could go wrong
- This is a small, early-phase dose-finding trial with only 21 participants, so results may not apply broadly. Abatacept also suppresses the immune system, which could reduce the anti-cancer effect of the immunotherapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
21 people
The number who actually took part.
- Started
-
Oct 2022
- Finished
-
Jan 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years old 2. Weight ≥ 40 kg and ≤ 125 kg 3. Patients treated with ICI immunotherapy (monotherapy or combination), including anti-PD1, anti-PDL1, anti-CTLA4; and including any type of cancer (even those in which ICI is not currently approved by regulatory) 4. Definite, probable or possible ICI-induced myocarditis according to the diagnostic criteria of the most recent expert consensus recommendations (e.g27, to be updated with any new recommendations to be published) 5. Severe or corticosteroid-resistant ICI-myocarditis: * Severe ICI-myocarditis is defined either 1/ by the appearance of an alteration of the LVEF\<50% or a wall motion kinetics abnormality, or 2/ by the appearance of ventricular tachycardias or high-grade conductive disorders (atrioventricular block grade 2 or 3) or 3/ by the association with myasthenia gravis-like-syndrome (diplopia, ptosis, diaphragmatic dysfunction, dysarthria, dysphonia, dysphagia) or 4/ by troponin-T levels above 32 times the upper limit of the normal (a population at very high-risk \~75% of major cardiomuscular events in the month following initial presentation, cf. Circulation. 2023 Aug 8;148(6):473-486). * Corticosteroid-resistant ICI-myocarditis is defined by the absence of decrease in troponin levels or the appearance/persistence of severity criteria despite receiving prednisone dose ≥0.5 mg/kg/day for ≥2 days. 6. Signature of informed consent before any trial procedure from the patient or legal representative or the close relative 7. Patients covered by social security regimen (excepting AME) 8. Withhold of ICI Exclusion Criteria: 1. Untreated and/or uncontrolled bacterial, fungal, or viral infection 2. Pregnancy, breast-feeding or planning to become pregnant during the study period 3. For women of childbearing age, lack of effective contraception throughout the duration of participation in the study 4. Being treated with abatacept or belatacept within 3 months prior to inclusion 5. Known hypersensitivity to abatacept or belatacept 6. Being treated with anti-thymoglobulin, or alemtuzumab within 6 weeks of the first scheduled dose of abatacept 7. Patient participating to another interventional study (RIPH 1 only) 8. People under legal protection measure (tutorship, curatorship or safeguard measures)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Myocarditis are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hôpital Pitié Salpêtrière
Paris, 75013, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A glowing dye could expose hidden heart scarring
- Immune clues in the blood may foretell heart trouble
- New PET tracer could spot hidden heart inflammation
- 5,000 patients to help unlock secrets of inflammatory heart disease
- New MRI scan could spot heart problems earlier
- Old gout drug may tame deadly heart inflammation