Clinical trial · Observational
Multiparametric Cardiac MRI in Patients Under CAR T-cell Therapy
Multiparametric Cardiac MRI in Oncological Patients Under Chimeric Antigen Receptor T-Cell Therapy
NCT05414162CI-TRIAL-00059122unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Recently chimeric antigen receptor (CAR) T-cell therapy, a new class of chemo therapy, has gained regulatory approval for the treatment of diseases such as B-cell lymphoma. Known side effects include cytokine release syndrome, which has been described to lead to myocarditis, but larger studies exploring this relationship are currently lacking. In this prospective study, the investigators aim to explore the potential effects of CAR T-cell therapy using cardiac MRI on the heart.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALL | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| CAR T-cell Therapy | — | UNRESOLVED | — |
| Cytokine Release Syndrome | — | UNRESOLVED | — |
| DLBCL | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| MCL | Mantle Cell Lymphoma | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myocarditis | — | UNRESOLVED | — |
| PCBCL | Primary Cutaneous B-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- CAR T-cell Therapy Group
- description
- Hematooncological patients undergoing CAR T-cell therapy with Tisagenlecleucel, Axicabtagen-ciloleucel, Idecabtagen-vicleucel, Brexucabtagene autoleucel, Lisocabtagene maraleucel or Ciltacabtagene Autoleucel (dosages, frequency and duration to be determined by the treating oncologist).
- interventionNames
- Diagnostic Test: Cardiac MRI
Primary outcomes (3)
- measure
- Extent and pattern of acute cardiac effects of CAR T-cell therapy
- timeFrame
- 2 weeks
- description
- To investigate to what extent and with which patterns CAR T cell therapy leads to acute cardiac effects in terms of inflammation, fibrosis, and myocardial dysfunction that can be detected with cardiac MRI.
- measure
- Long-term cardiac remodeling effects of CAR T-cell therapy
- timeFrame
- 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing CAR T-cell therapy * Consent to participate in study Exclusion Criteria: * Inability to undergo MRI examinations due to large metallic implants, cardiac pacemakers/neurostimulators, or claustrophobia * Known cardiac conditions such as status post heart attack or myocarditis, complex congenital heard disease, or cardiomyopathies. * Birth control using an IUD. * Pregnancy or breastfeeding. * Renal insufficiency with a GFR below 30 ml/min/1.73m2
References
Publications (23)
- BACKGROUNDGross G, Waks T, Eshhar Z. Expression of immunoglobulin-T-cell receptor chimeric molecules as functional receptors with antibody-type specificity. Proc Natl Acad Sci U S A. 1989 Dec;86(24):10024-8. doi: 10.1073/pnas.86.24.10024. PMID 2513569
- BACKGROUNDRazeghian E, Nasution MKM, Rahman HS, Gardanova ZR, Abdelbasset WK, Aravindhan S, Bokov DO, Suksatan W, Nakhaei P, Shariatzadeh S, Marofi F, Yazdanifar M, Shamlou S, Motavalli R, Khiavi FM. A deep insight into CRISPR/Cas9 application in CAR-T cell-based tumor immunotherapies. Stem Cell Res Ther. 2021 Jul 28;12(1):428. doi: 10.1186/s13287-021-02510-7. PMID 34321099
- BACKGROUNDMohanty R, Chowdhury CR, Arega S, Sen P, Ganguly P, Ganguly N. CAR T cell therapy: A new era for cancer treatment (Review). Oncol Rep. 2019 Dec;42(6):2183-2195. doi: 10.3892/or.2019.7335. Epub 2019 Sep 24. PMID 31578576
- BACKGROUNDSermer D, Brentjens R. CAR T-cell therapy: Full speed ahead. Hematol Oncol. 2019 Jun;37 Suppl 1:95-100. doi: 10.1002/hon.2591. PMID 31187533
- BACKGROUNDYanez L, Alarcon A, Sanchez-Escamilla M, Perales MA. How I treat adverse effects of CAR-T cell therapy. ESMO Open. 2020 Aug;4(Suppl 4):e000746. doi: 10.1136/esmoopen-2020-000746. PMID 32839196
- BACKGROUNDLee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25. PMID 30592986
- BACKGROUNDAfzal A, Farooque U, Gillies E, Hassell L. T-cell Therapy-Mediated Myocarditis Secondary to Cytokine Release Syndrome. Cureus. 2020 Aug 25;12(8):e10022. doi: 10.7759/cureus.10022.