Clinical trials: Immune Effector Cell-Associated Neurotoxicity Syndrome
Cytokine Release Syndrome, ICANS
Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy
This study will evaluate the use of siltuximab to decrease the severity of cytokine release syndrome (CRS) and immune effector cell-associated neurological syndrome (ICANS) in patients who will receive chimeric antigen receptor…
- Conditions
- Cytokine Release Syndrome, ICANS, Lymphoma, Non-Hodgkin, Multiple Myeloma
- Trial name
- NCT04975555
- Testing
- Siltuximab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Alabama at Birmingham
B Cell Malignancies, B-cell Leukemia
Bispecific CAR T Cells for B-cell Malignancies (BaseCAR-01 Trial)
This study is to provide locally produced, bispecific CD19 CD20 CAR T cells to patients with B-cell lymphoma/leukemia who have no access to commercial CAR T cells or who have relapsed thereafter.
- Conditions
- B Cell Malignancies, B-cell Leukemia, B Cell Lymphoma, Bispecific Chimeric Antigen Receptor (CAR) T Cells
- Trial name
- BaseCAR-01 (NCT07166549)
- Testing
- Experimental Intervention
- Where
- Switzerland
- Volunteers
- 12 people
- Sponsor
- University Hospital, Basel, Switzerland
Cytokine Release Syndrome
A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
"The purpose of this study is to assess the safety and efficacy of oral administration of itacitinib for the prevention of cytokine release syndrome (CRS) in male or female participants aged 12 years or older and who are planning…
- Trial name
- NCT04071366
- Testing
- Itacitinib, Immune effector cell therapy, Yescarta
- Where
- 10 sites in United States
- Volunteers
- 112 people
- Sponsor
- Incyte Corporation
Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome
RPM Signals in Outpatient CAR T Therapy
The goal of this observational study is to learn how patients' vital signs and symptoms change during outpatient CAR T-cell therapy with lisocabtagene maraleucel (liso-cel), a type of cancer treatment.
- Conditions
- Cytokine Release Syndrome, Immune Effector Cell-Associated Neurotoxicity Syndrome, B-Cell Lymphoma, Chronic Lymphocytic Leukemia
- Trial name
- NCT07882732
- Volunteers
- 125 people
- Sponsor
- Current Health
Lymphoma, B-Cell, Neurotoxicity
Magnetic Resonance Imaging in Immune Effector Cell-Associated Neurotoxicity Syndrome
The treatment of large-cell B-cell lymphomas refractory to more than 2 lines of therapy has recently been revolutionized by the use of immunotherapies consisting of autologous genetically modified cells or CAR-T CELLS (chimeric…
- Trial name
- MR-ICANS (NCT05510596)
- Testing
- Magnetic Resonance Imaging with contrast injection, Blood withdrawal, Neuropsychological tests
- Where
- France
- Volunteers
- 25 people
- Sponsor
- University Hospital, Montpellier
CRS - Cytokine Release Syndrome, Myeloma
A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
- Trial name
- NCT07106671
- Testing
- Siltuximab
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Immune Effector Cell Associated Neurotoxicity Syndrome
Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome
CAR T-cell therapy is a promising innovative therapy for hematological malignancies. Immune effectors cells-associated neurotoxicity syndrome (ICANS) is a significant complication of CAR therapy.
- Trial name
- NCT05643092
- Where
- China
- Volunteers
- 50 people
- Sponsor
- zhang shoulong
Multiple Myeloma, Cytokine Release Syndrome
Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM
The purpose of this study is to examine the safety, efficacy and feasibility of the use of one standard dose of siltuximab prior to teclistamab infusion.
- Conditions
- Multiple Myeloma, Cytokine Release Syndrome, Refractory Multiple Myeloma, Immune Effector Cell Associated Neurotoxicity Syndrome
- Trial name
- NCT06352866
- Testing
- Siltuximab, Teclistamab(FDA-approved)
- Where
- United States
- Sponsor
- Jack Khouri, MD
Refractory Multiple Myeloma
Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma
A phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of…
- Trial name
- EMBRACE (NCT06421675)
- Testing
- Elranatamab injection
- Where
- 6 sites in Canada
- Volunteers
- 40 people
- Sponsor
- Ontario Clinical Oncology Group (OCOG)
Cytokine Release Syndrome, ICANS
Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study
This Phase I, prospective, single-arm clinical study aims to evaluate the efficacy and safety of adjunctive methylene blue (MB) in patients experiencing cytokine release syndrome (CRS) or immune effector cell-associated…
- Trial name
- NCT07169487
- Testing
- Methylene Blue
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
B-Acute Lymphoblastic Leukemia, CAR-T Cell Therapy
Pre-emptive Anakinra for Cytokine Event Reduction
Objectives: The primary objective of this study will be to evaluate the impact of pre-emptive use of anakinra on the rate of severe cytokine release syndrome (CRS) following CD19-directed chimeric antigen receptor (CAR) T-cell…
- Conditions
- B-Acute Lymphoblastic Leukemia, CAR-T Cell Therapy, Cytokine Release Syndrome, Immune Effector Cell Associated Neurotoxicity Syndrome
- Trial name
- PACER (NCT06703216)
- Testing
- Anakinra (Kineret®)
- Where
- United States
- Sponsor
- Kevin McNerney
Immune Effector Cell Associated Neurotoxicity Syndrome
Temporal Characterization of Extracellular Vesicles During Cellular Therapy Using CAR-T Cells and During the Occurrence of Immune Effector Cell-Associated Neurotoxicity Syndrome
Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS) is a common and serious neurological complication associated with the use of CAR-T cells.
- Trial name
- VESICANS (NCT06706102)
- Testing
- Biological tests, MRI, Neuropsychological tests
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Immune Effector Cell Encephalopathy, Neurotoxicity
EEG Encephalopathy Patterns in Immune Effectors Cells-associated Neurotoxicity Syndrome (ICANS)Lay Language
Immune effectors cells-associated neurotoxicity syndrome (ICANS) is one of the most clearly defined acute toxicities after CAR-T cells infusion.
- Trial name
- NCT05040230
- Where
- France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Montpellier
Multiple Myeloma, Large B-cell Lymphoma (LBCL)
Emapalumab Prophylaxis of Bispecific T-Cell Engagers (BiTEs) Associated CRS and ICANS
The purpose of this study is to evaluate emapalumab as a prophylactic therapy in preventing cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in patients with hematologic…
- Trial name
- NCT07567014
- Testing
- Emapalumab
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- NYU Langone Health
Multiple Myeloma
Outpatient Administration of Teclistamab or Talquetamab for Multiple Myeloma
This is a phase II study to evaluate the outpatient administration of Teclistamab or Talquetamab in Multiple Myeloma patients
- Trial name
- NCT05972135
- Testing
- Teclistamab, Talquetamab, Tocilizumab
- Where
- 17 sites in United States
- Volunteers
- 100 people
- Sponsor
- SCRI Development Innovations, LLC
Neurotoxicity, Neurotoxicity Syndromes
Assessing DCog Short for Neurotoxicity in CAR-T
The aim of this study is to determine the effectiveness of DCog Short, a self-reporting, iPad-based application tool, in assessing neurotoxicity in participants undergoing CAR-T cell therapy.
- Conditions
- Neurotoxicity, Neurotoxicity Syndromes, Hematologic Malignancy, Immune Effector Cell Associated Neurotoxicity Syndrome
- Trial name
- NCT07403812
- Testing
- DCog Short
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Beth Israel Deaconess Medical Center
Lymphoma, Myeloma
Multimodal Telerehabilitation in Patients Undergoing CAR-T Cell Immunotherapy
The proposed multimodal telerehabilitation model allows a rehabilitation therapy team to set up individualized rehabilitation plans using a web-based care management portal and monitor patient progress online.
- Conditions
- Lymphoma, Myeloma, Cytokine Release Syndrome, Immune Effector Cell Associated Neurotoxicity Syndrome
- Trial name
- NCT07390071
- Testing
- Home Automated Telemanagement (HAT) Patient Unit
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Utah