81/22Recruiting

Observational Study on the Cardiac Side Effects of CAR-T Cell Therapy

Gender
Women and men
Age
18 years and older
Trial type
Observational
Line of therapy
all
Phase

What is this trial about?

CAR-T cell therapy is a relatively new class of therapy used to treat various, mostly malignant blood cancers. In this therapy, the patient’s immune cells are genetically modified so that they attack the tumor cells. However, this therapy can have side effects. For example, there is evidence that the therapy could trigger inflammation of the heart muscle (myocarditis). The aim of this study is to investigate the effects of CAR-T cell therapy on the heart using cardiac magnetic resonance imaging. Eligible participants are adult women and men who are receiving CAR-T cell therapy as part of their treatment for their disease and who are willing to undergo a total of 3 cardiac MRI scans.

Detailed description

CAR-T cell therapy is a new treatment method that uses the patient’s genetically modified T cells to recognize and kill specific cells in the body, thereby activating the body’s own immune system. To date, this therapy has been used primarily to treat malignant blood cancers. Although generally safe, CAR-T cell therapy can have side effects, including those affecting the cardiovascular system, and may also cause inflammation of the heart muscle (myocarditis).

This study investigates heart-specific side effects following CAR-T cell therapy using multiple cardiac magnetic resonance imaging (cardiac MRI) scans. The study is purely observational; no medications are being tested in this study; participation in the study does not alter the treatment itself. The study is conducted prospectively and longitudinally, which means that patients are monitored over an extended period to examine both acute and long-term effects on the heart. Patients will undergo a total of three cardiac MRIs: at the start of treatment, within two weeks of the start of therapy, and after six months. These scans help identify inflammation, scarring (fibrosis), and changes in heart function, and track their progression in relation to CAR-T cell therapy.

Eligible participants include women and men who are being treated with CAR-T cell therapy or for whom such therapy is planned, and who are willing to undergo multiple MRI scans.

Facts

  1. Which diseases: in principle, all diseases for which CAR-T cell therapy is used.
  2. Cancer characteristics: Patients undergoing or scheduled to undergo CAR-T cell therapy.
  3. What the study investigates: cardiac effects of CAR-T cell therapy using cardiac MRI.
  4. Study objective: To assess and analyze cardiac damage (inflammation, fibrosis, function) caused by CAR-T cell therapy using MRI.
  5. How long will the study last: Total duration approximately 3.5 years, with 3 MRI scans per patient spread over 6 months.
  6. Study characteristics: prospective, longitudinal observational study; unblinded (open-label); no testing of a novel drug.

Trial sites

1 trial site in Germany is listed.

  • Universitätsklinikum Bonn

    Venusberg-Campus 1, 53127 Bonn

    Recruiting

This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.

Medical editorial team

  • Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
  • PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine

This description is based on the public trial registry (NCT05414162) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.