Multiparametric Cardiac MRI in Patients Under CAR T-cell Therapy
NCT ID: NCT05414162
Last Updated: 2022-06-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
60 participants
Study Classification
OBSERVATIONAL
Study Start Date
2022-05-16
Study Completion Date
2025-12-31
Brief Summary
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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.
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Detailed Description
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Genetically modified chimeric antigen receptor (CAR) T cells specifically targeting CD19 or "B cell maturation antigen" (BCMA) have shown remarkable advances in the treatment of highly refractory and relapsing hematological malignancies including diffuse large B-cell lymphoma or multiple myeloma. However, this potent therapy is hampered by serious, potentially life threatening complications, which might also involve the cardiovascular system. The potential cardiotoxic profile remains poorly defined and insufficiently understood. This proposal describes a prospective, longitudinal, intraindividual cardiac magnetic resonance imaging (MRI) study in oncological patients, which are scheduled for CAR T cell therapy for cancer treatment. This explorative study is designed to evaluate and monitor acute and late effects of CAR T cell therapy on the heart muscle. Systematic cardiac MRI monitoring correlated with the clinical course and thorough immunological assessment is the next step in helping to understand the extent, pattern, and pathophysiology of CAR T cell therapy related cardiovascular adverse events.
A chimeric antigen receptor (CAR) is a recombinant fusion protein that activates T cells upon recognition of a specific antigen on the cell surface of target cells. Therapeutic success was especially noticed with CD19-specific CAR T cells in the treatment of highly refractory and relapsing hematological malignancies. CD19 is an effective target due to its expression throughout the development line of B cells and has a frequent and high-level expression on the surface of nearly all B-cell malignancies. In addition, it is not found on other normal tissue cells, including the heart, and is not shed as a soluble form. The process of manufacturing CAR T cells typically requires 3 to 4 weeks. Autologous T cells are first collected from the patient and then genetically modified ex vivo with lentiviral or retroviral vectors to reprogram the T cells to recognize tumor cells expressing a tumor associated antigen (e.g., CD19 or BCMA). The CAR T cells a multiplied in large quantities before being administered to the patient within a single infusion. Before the infusion of CAR T cells, patients undergo lymphodepleting chemotherapy, most commonly with a combination of fludarabine and cyclophosphamide. This suppresses the patient's endogenous T cell compartment and allows an in vivo expansion of the transferred CAR T cells. Although the CAR T cell therapy has clearly advanced the treatment of highly refractory or relapsing hematological malignancies, there are potentially severe drawbacks of this therapy. One especially worrisome shortcoming is the potential therapy association with the unique toxicities of a cytokine release syndrome (CRS) and neurologic toxicities.
Cardiovascular complications associated with CAR T cell therapy are less well defined but can be subclassified into autoimmune toxicities resulting from antigen-specific T cell infiltration of the heart and cytokine-mediated toxicities. Cytokine-associated cardiotoxicities have been reported especially in the setting of CRS and might be the cause for most of the observed cardiovascular side effects. In a retrospective study from Alvi et al. cardiovascular events were systematically investigated in adults treated with CAR T cell therapy. The study included 137 patients and found that up to 12% of patients had clinical apparent cardiovascular events after CAR T cell therapy initiation (median time to event 21 days). Cardiovascular events included cardiovascular death, new onset heart failure, decompensated heart failure, and new onset of arrhythmia. A decrease in left ventricular function was observed in 28% of patients while 54% of patients had an elevated troponin. Interestingly, all cardiovascular events occurred in patients with grade ≥ 2 CRS and 95% of events occurred after troponin elevation. Another retrospective study from Lefebvre et al. investigated the occurrence of major adverse cardiovascular events (MACE) in 145 adult patients treated with CAR T cell therapy. MACE included cardiovascular death, symptomatic heart failure, acute coronary syndrome, ischemic stroke, and new onset arrhythmias. In total, 31 out of 145 (21%) patients had MACE at a median time of 11 days after CAR T cell infusion. MACE was independently associated with CRS grade 3 or 4 and baseline creatinine. Overall survival after one year was 71%. Another retrospective study analyzing 116 patients with serial echocardiograms after CAR T cell therapy found that 10% of patients developed a new cardiomyopathy with a decrease of left ventricular ejection fraction (average decrease from 58% to 37%), mostly observed in patients with grade ≥ 2 CRS. Another study with a patient pool of 126, found that 10% of patients developed severe cardiac disorders after CAR T cell therapy including new onset heart failure, acute coronary syndrome, and myocardial infarction.
Cardiac MRI for assessment of acute and chronic cardiac effects in CAR T cell therapy As the impact and the pathophysiology of cardiotoxicity of CAR T cell therapies to the heart is poorly understood, it is still unclear, whether cardiotoxicity is simply an early phenomenon associated with the cytokine storm within the scope of the CRS or whether there are more direct cardiotoxic effects from the CAR T cells themselves. It has also been proposed that the observed systolic dysfunction in this setting is a sequalae of a stress induced Takotsubo syndrome. In this context, the physiological stress from the CRS could trigger the occurrence of Takotsubo syndrome. To explore the extent of cardiac injury and inflammation and the pattern of myocardial involvement related to CAR T cell therapy, cardiac MRI must be considered as the imaging modality of choice, particularly due to its inherent capabilities of advanced tissue characterization. Cardiac MRI can characterize myocardial tissue alterations, analyze involvement patterns, and give important insights into the remodeling processes. To date, no cardiac MRI studies in patients with CAR T cell therapy exist. However, in this context, multiparametric cardiac MRI can be used to detect and quantify acute diffuse myocardial tissue alterations, such as myocardial edema and fibrosis. Furthermore, alterations in myocardial function can be detected with high sensitivity by using myocardial strain analysis. Late gadolinium enhancement imaging has a very high specificity for the detection of necrotic inflammatory lesions, especially in the context of inflammatory cardiomyopathies, and could directly show inflammatory lesions associated with CAR T cell therapy. Also, cardiac MRI could reliably identify different patterns of wall motion abnormalities which are associated with Takotsubo syndrome (i.e., apical, midventricular, basal or focal types). A recent study from our group in patients under immune checkpoint inhibitors (ICI) for cancer treatment suggests that cardiac MRI is able to show subtle therapy related treatment effects and can support evidence of a specific imaging pattern of ICI-related myocarditis. Also, cardiac MRI is the imaging modality of choice to show longterm, cardiotoxic effects of chemotherapy. It is considered the reference standard for measurement of ventricular volumes and function making it ideally suited to assess adverse cardiac remodeling after termination of cancer treatment.
A chimeric antigen receptor (CAR) is a recombinant fusion protein that activates T cells upon recognition of a specific antigen on the cell surface of target cells. Therapeutic success was especially noticed with CD19-specific CAR T cells in the treatment of highly refractory and relapsing hematological malignancies. CD19 is an effective target due to its expression throughout the development line of B cells and has a frequent and high-level expression on the surface of nearly all B-cell malignancies. In addition, it is not found on other normal tissue cells, including the heart, and is not shed as a soluble form. The process of manufacturing CAR T cells typically requires 3 to 4 weeks. Autologous T cells are first collected from the patient and then genetically modified ex vivo with lentiviral or retroviral vectors to reprogram the T cells to recognize tumor cells expressing a tumor associated antigen (e.g., CD19 or BCMA). The CAR T cells a multiplied in large quantities before being administered to the patient within a single infusion. Before the infusion of CAR T cells, patients undergo lymphodepleting chemotherapy, most commonly with a combination of fludarabine and cyclophosphamide. This suppresses the patient's endogenous T cell compartment and allows an in vivo expansion of the transferred CAR T cells. Although the CAR T cell therapy has clearly advanced the treatment of highly refractory or relapsing hematological malignancies, there are potentially severe drawbacks of this therapy. One especially worrisome shortcoming is the potential therapy association with the unique toxicities of a cytokine release syndrome (CRS) and neurologic toxicities.
Cardiovascular complications associated with CAR T cell therapy are less well defined but can be subclassified into autoimmune toxicities resulting from antigen-specific T cell infiltration of the heart and cytokine-mediated toxicities. Cytokine-associated cardiotoxicities have been reported especially in the setting of CRS and might be the cause for most of the observed cardiovascular side effects. In a retrospective study from Alvi et al. cardiovascular events were systematically investigated in adults treated with CAR T cell therapy. The study included 137 patients and found that up to 12% of patients had clinical apparent cardiovascular events after CAR T cell therapy initiation (median time to event 21 days). Cardiovascular events included cardiovascular death, new onset heart failure, decompensated heart failure, and new onset of arrhythmia. A decrease in left ventricular function was observed in 28% of patients while 54% of patients had an elevated troponin. Interestingly, all cardiovascular events occurred in patients with grade ≥ 2 CRS and 95% of events occurred after troponin elevation. Another retrospective study from Lefebvre et al. investigated the occurrence of major adverse cardiovascular events (MACE) in 145 adult patients treated with CAR T cell therapy. MACE included cardiovascular death, symptomatic heart failure, acute coronary syndrome, ischemic stroke, and new onset arrhythmias. In total, 31 out of 145 (21%) patients had MACE at a median time of 11 days after CAR T cell infusion. MACE was independently associated with CRS grade 3 or 4 and baseline creatinine. Overall survival after one year was 71%. Another retrospective study analyzing 116 patients with serial echocardiograms after CAR T cell therapy found that 10% of patients developed a new cardiomyopathy with a decrease of left ventricular ejection fraction (average decrease from 58% to 37%), mostly observed in patients with grade ≥ 2 CRS. Another study with a patient pool of 126, found that 10% of patients developed severe cardiac disorders after CAR T cell therapy including new onset heart failure, acute coronary syndrome, and myocardial infarction.
Cardiac MRI for assessment of acute and chronic cardiac effects in CAR T cell therapy As the impact and the pathophysiology of cardiotoxicity of CAR T cell therapies to the heart is poorly understood, it is still unclear, whether cardiotoxicity is simply an early phenomenon associated with the cytokine storm within the scope of the CRS or whether there are more direct cardiotoxic effects from the CAR T cells themselves. It has also been proposed that the observed systolic dysfunction in this setting is a sequalae of a stress induced Takotsubo syndrome. In this context, the physiological stress from the CRS could trigger the occurrence of Takotsubo syndrome. To explore the extent of cardiac injury and inflammation and the pattern of myocardial involvement related to CAR T cell therapy, cardiac MRI must be considered as the imaging modality of choice, particularly due to its inherent capabilities of advanced tissue characterization. Cardiac MRI can characterize myocardial tissue alterations, analyze involvement patterns, and give important insights into the remodeling processes. To date, no cardiac MRI studies in patients with CAR T cell therapy exist. However, in this context, multiparametric cardiac MRI can be used to detect and quantify acute diffuse myocardial tissue alterations, such as myocardial edema and fibrosis. Furthermore, alterations in myocardial function can be detected with high sensitivity by using myocardial strain analysis. Late gadolinium enhancement imaging has a very high specificity for the detection of necrotic inflammatory lesions, especially in the context of inflammatory cardiomyopathies, and could directly show inflammatory lesions associated with CAR T cell therapy. Also, cardiac MRI could reliably identify different patterns of wall motion abnormalities which are associated with Takotsubo syndrome (i.e., apical, midventricular, basal or focal types). A recent study from our group in patients under immune checkpoint inhibitors (ICI) for cancer treatment suggests that cardiac MRI is able to show subtle therapy related treatment effects and can support evidence of a specific imaging pattern of ICI-related myocarditis. Also, cardiac MRI is the imaging modality of choice to show longterm, cardiotoxic effects of chemotherapy. It is considered the reference standard for measurement of ventricular volumes and function making it ideally suited to assess adverse cardiac remodeling after termination of cancer treatment.
Conditions
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DLBCL
Multiple Myeloma
Cytokine Release Syndrome
Myocarditis
CAR T-cell Therapy
ALL
PCBCL
Follicular Lymphoma
MCL
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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CAR T-cell Therapy Group
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).
Cardiac MRI
Intervention Type
DIAGNOSTIC_TEST
Hematooncology patients under CAR T-cell therapy will receive 3 MRI examinations: at baseline, within 2 weeks of start of CAR T-cell therapy, and at 6 months follow-up.
Interventions
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Cardiac MRI
Hematooncology patients under CAR T-cell therapy will receive 3 MRI examinations: at baseline, within 2 weeks of start of CAR T-cell therapy, and at 6 months follow-up.
Intervention Type
DIAGNOSTIC_TEST
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing CAR T-cell therapy
* Consent to participate in study
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Bonn
OTHER
Sponsor Role
lead
Responsible Party
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Julian Alexander Luetkens
Head of Cardiovascular Imaging, Principal Investigator, Senior Physician
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Julian Luetkens, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bonn
Annkristin Heine, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bonn
Tobias Holderried, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bonn
Dmitrij Kravchenko, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bonn
Locations
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University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany
Site Status
RECRUITING
Countries
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Germany
Central Contacts
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Facility Contacts
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References
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BACKGROUND
Afzal 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.
Reference Type
BACKGROUND
Ganatra S, Redd R, Hayek SS, Parikh R, Azam T, Yanik GA, Spendley L, Nikiforow S, Jacobson C, Nohria A. Chimeric Antigen Receptor T-Cell Therapy-Associated Cardiomyopathy in Patients With Refractory or Relapsed Non-Hodgkin Lymphoma. Circulation. 2020 Oct 27;142(17):1687-1690. doi: 10.1161/CIRCULATIONAHA.120.048100. Epub 2020 Oct 26. No abstract available.
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BACKGROUND
Ghosh AK, Chen DH, Guha A, Mackenzie S, Walker JM, Roddie C. CAR T Cell Therapy-Related Cardiovascular Outcomes and Management: Systemic Disease or Direct Cardiotoxicity? JACC CardioOncol. 2020 Mar 17;2(1):97-109. doi: 10.1016/j.jaccao.2020.02.011. eCollection 2020 Mar.
Reference Type
BACKGROUND
Luetkens JA, Doerner J, Thomas DK, Dabir D, Gieseke J, Sprinkart AM, Fimmers R, Stehning C, Homsi R, Schwab JO, Schild H, Naehle CP. Acute myocarditis: multiparametric cardiac MR imaging. Radiology. 2014 Nov;273(2):383-92. doi: 10.1148/radiol.14132540. Epub 2014 Jun 6.
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BACKGROUND
Friedrich MG, Sechtem U, Schulz-Menger J, Holmvang G, Alakija P, Cooper LT, White JA, Abdel-Aty H, Gutberlet M, Prasad S, Aletras A, Laissy JP, Paterson I, Filipchuk NG, Kumar A, Pauschinger M, Liu P; International Consensus Group on Cardiovascular Magnetic Resonance in Myocarditis. Cardiovascular magnetic resonance in myocarditis: A JACC White Paper. J Am Coll Cardiol. 2009 Apr 28;53(17):1475-87. doi: 10.1016/j.jacc.2009.02.007.
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BACKGROUND
Sprinkart AM, Luetkens JA, Traber F, Doerner J, Gieseke J, Schnackenburg B, Schmitz G, Thomas D, Homsi R, Block W, Schild H, Naehle CP. Gradient Spin Echo (GraSE) imaging for fast myocardial T2 mapping. J Cardiovasc Magn Reson. 2015 Feb 12;17(1):12. doi: 10.1186/s12968-015-0127-z.
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Luetkens JA, Faron A, Isaak A, Dabir D, Kuetting D, Feisst A, Schmeel FC, Sprinkart AM, Thomas D. Comparison of Original and 2018 Lake Louise Criteria for Diagnosis of Acute Myocarditis: Results of a Validation Cohort. Radiol Cardiothorac Imaging. 2019 Jul 25;1(3):e190010. doi: 10.1148/ryct.2019190010. eCollection 2019 Aug.
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Luetkens JA, Homsi R, Dabir D, Kuetting DL, Marx C, Doerner J, Schlesinger-Irsch U, Andrie R, Sprinkart AM, Schmeel FC, Stehning C, Fimmers R, Gieseke J, Naehle CP, Schild HH, Thomas DK. Comprehensive Cardiac Magnetic Resonance for Short-Term Follow-Up in Acute Myocarditis. J Am Heart Assoc. 2016 Jul 19;5(7):e003603. doi: 10.1161/JAHA.116.003603.
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Kravchenko D, Isaak A, Zimmer S, Mesropyan N, Reinert M, Faron A, Pieper CC, Heine A, Velten M, Nattermann J, Kuetting D, Duerr GD, Attenberger UI, Luetkens JA. Cardiac MRI in Patients with Prolonged Cardiorespiratory Symptoms after Mild to Moderate COVID-19. Radiology. 2021 Dec;301(3):E419-E425. doi: 10.1148/radiol.2021211162. Epub 2021 Aug 10.
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Luetkens JA, Doerner J, Schwarze-Zander C, Wasmuth JC, Boesecke C, Sprinkart AM, Schmeel FC, Homsi R, Gieseke J, Schild HH, Rockstroh JK, Naehle CP. Cardiac Magnetic Resonance Reveals Signs of Subclinical Myocardial Inflammation in Asymptomatic HIV-Infected Patients. Circ Cardiovasc Imaging. 2016 Mar;9(3):e004091. doi: 10.1161/CIRCIMAGING.115.004091.
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Luetkens JA, von Landenberg C, Isaak A, Faron A, Kuetting D, Gliem C, Dabir D, Kornblum C, Thomas D. Comprehensive Cardiac Magnetic Resonance for Assessment of Cardiac Involvement in Myotonic Muscular Dystrophy Type 1 and 2 Without Known Cardiovascular Disease. Circ Cardiovasc Imaging. 2019 Jun;12(6):e009100. doi: 10.1161/CIRCIMAGING.119.009100. Epub 2019 May 29. No abstract available.
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Faron A, Isaak A, Mesropyan N, Reinert M, Schwab K, Sirokay J, Sprinkart AM, Bauernfeind FG, Dabir D, Pieper CC, Heine A, Kuetting D, Attenberger U, Landsberg J, Luetkens JA. Cardiac MRI Depicts Immune Checkpoint Inhibitor-induced Myocarditis: A Prospective Study. Radiology. 2021 Dec;301(3):602-609. doi: 10.1148/radiol.2021210814. Epub 2021 Sep 28.
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Reference Type
BACKGROUND
Other Identifiers
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81/22
Identifier Type: -
Identifier Source: org_study_id
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