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RecruitingNCT06350994Cardio CAR-TUpdated Sep 2, 2025

Early Assessment of Cardiac Function After Treatment With CAR-T Cells

An observational study in Car T- Cell, Hematologic Malignancy and Acute Lymphoblastic Leukemia, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications.

Among the most frequent complications are the risk of infection, cytokine release syndrome (CRS) and neurotoxicity. Nevertheless, some authors have reported serious acute cardiac events in a limited number of patients, often contemporaneous with CRS or sepsis, questioning the imputability of CAR-T cells in this heart disease.

This study aims to estimate the incidence of a possible early cardiotoxicity associated with CAR-T cells.

The main endpoint will be the change in cardiac function (LVEF: left ventricular ejection fraction) assessed by ultrasound between the pre CAR-T assessment and the early post CAR-T ultrasound (D3-D5).

Read the detailed description

CAR-T cells (Chimeric Antigen Receptor) represent a new form of immunotherapy, based on the genetic modification of autologous T lymphocytes collected after apheresis, allowing the recognition of a tumor antigen apart from the presentation by the major complex of histocompatibility (MHC). Treatment with CAR-T cells constitutes a major therapeutic advance in patients with refractory hematological malignancies.

Nevertheless, CAR-T cell therapy is often associated with severe complications leading them to the ICU in >25%.

Among the most frequent complications are the risk of infection cytokine release syndrome (CRS)and neurotoxicity. A recent study reported serious acute cardiac events in the days following the administration of CAR-T cells in 6.5% of patients (12/187). In this work, patients did not benefit from systematic early echocardiography, but only in the event of CRS grade ≥2 or symptoms, with a risk of underdiagnosis of asymptomatic forms. Since the vast majority of reported cases are contemporaneous with CRS or sepsis, the imputability of CAR-Ts in this heart disease is debated.

The Cardio CAR-T study aims to investigate a possible early cardiac toxicity of CAR-T cells, screened by transthoracic echocardiography at the patient's bedside, between D3 and D5 after injection of CAR-T cells (period at which the inflammatory complications of this treatment occur in the majority of cases) associated with the description of routine examinations (BNP, Troponin and ECG) and cytokine analyses.

This pilot descriptive study would answer 2 questions:

  • What are the incidence and characteristics of acute cardiac toxicity (clinical and subclinical) of CAR-T cells and their association with CRS?
  • Is there a link between cardiac toxicity and the intensity of the cytokine inflammatory response? This makes it possible to provide new pathophysiological elements on the existence of a heart disease directly caused by the inflammatory storm, applicable to other areas such as septic shock, ischemia-reperfusion or major surgery.
02

Conditions studied

  • Car T- Cell
  • Hematologic Malignancy
  • Acute Lymphoblastic Leukemia
  • Lymphoma, B-Cell
  • Multiple Myeloma

Keywords

  • CAR-T cells
  • Hematological malignancies
  • Cardiomyopathy
  • Cardiotoxicity
  • Pharmacovigilance
03

In context

Hematologic Neoplasms

1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.

This study's planned enrollment of 60 is below the median of 186 across 322 observational studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

Browse Assistance Publique - Hôpitaux de Paris studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients (>18 years old) receiving CAR-T cell therapy for hematological malignancies (acute lymphoblastic -B cell leukemia, lymphoma and multiple myeloma) hospitalized in hematology department or in intensive care unit.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • CAR-T cells infusion received within 3 to 5 days before the echocardiography
  • Pre-therapeutic cardiac assessment (in accordance with the recommendations and standard care protocol in force in the hematology department of Saint-Antoine Hospital): Echocardiography and before conditioning and infusion of CAR -T cells,
  • Not opposed to participating in research.
  • Patient affiliated to a social security system or beneficiary of the "state medical insurance help" (namely aide médicale d'état).

Exclusion criteria

Exclusion Criteria:

  • Opposition or consent withdrawal
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Cardio CAR-T

    Transthoracic bedside echocardiography

06

What researchers measure

Primary outcomes

  1. Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity

    Transthoracic bedside echocardiographic evaluation of the LVEF.

    Time frame: 5 days and 3 months

Secondary outcomes

  1. Characterization of the putative CAR-T cells infusion-induced cardiotoxicity: incidence, phenotype, clinical, rhythmic and biological manifestations

    Transthoracic bedside echocardiographic evaluation of the LVEF, EKG, biologicals (troponin, BNP).

    Time frame: 5 days and 3 months

  2. Determination of its possible association with a cytokine release syndrome and the levels of inflammatory biomarkers from the analysis of the serum library of these patients

    Multiplex bioassays for immune-inflammatory biomarkers.

    Time frame: 5 days and 3 months

07

Study locations

1 of 1 sites recruiting
  • Critical care medicine department
    Paris, 75012, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Dec 2026, 25 months after the start.

Of 164 non-industry observational studies under Hematologic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 322. This study's planned 25 months is below that.

Counting every sponsor, half of 186 studies reached it within 74 months; a quarter within 34 and three quarters within 322.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 21, 2024
First posted
Apr 8, 2024
StartActual
Nov 7, 2024
Primary completionEst.
Dec 2026
CompletionEst.
Mar 2027
Last update
Sep 2, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06350994
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Apr 8, 2024
Start date
Nov 7, 2024
Primary completion
Dec 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 2, 2025

Study contacts

Jérémie JOFFRE, MD, PhD
Contact
Jeremie.joffre@aphp.fr
+33 1 49 28 21 45
Hafid AIT-OUFELLA, Professor
Contact
hafid.ait-oufella@aphp.fr
+33 1 49 28 21 45
Jérémie JOFFRE
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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