Clinical trials: ICANS
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
Non-hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma
Intrathecal Cytarabine and Hydrocortisone for the Early Treatment of ICANS in Patients Undergoing CAR T Therapy for Non Hodgkin Lymphoma
The goal of this clinical trial is to reduce the duration of ICANS and incidence of G3 or great ICANS in participants who receive axi-cel.
- Conditions
- Non-hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma
- Trial name
- NCT07763210
- Testing
- Therapeutic Hydrocortisone, Cytarabine, Dexamethasone
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
HIV-1-infection, ART
Ph1 Study of FT538 Alone and With Vorinostat for Persistent Low-Level HIV Viremia
This is a single center Phase I clinical trial of FT538 administered intravenously (IV) once every 14 days for 4 consecutive doses for the reduction of the HIV reservoir in lymphoid tissue of HIV-infected individuals receiving…
- Conditions
- HIV-1-infection, ART, Cd4+ Lymphocyte Deficiency, Lymphoid Tissue; Infection
- Trial name
- NCT05700630
- Testing
- FT538, Vorinostat
- Where
- United States
- Sponsor
- Masonic Cancer Center, University of Minnesota
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
ICANS, Grade Unspecified, CAR T-Cell-Related Encephalopathy Syndrome
Multicenter Study Using IMC to Analyze the Impact of ICANS on Microglia
Immunotherapy with chimeric antigen receptor (CAR) T cell therapy can cause immune effector cell-associated neurotoxicity syndrome (ICANS). However, the molecular mechanisms leading to ICANS are not well understood.
- Trial name
- NCT05811117
- Testing
- There will be no intervention as we will study patients that undergo autopsy after CAR T cell infusion.
- Where
- Germany
- Volunteers
- 8 people
- Sponsor
- University of Freiburg
Acute Lymphoblastic Leukemia, Immune System Diseases
Administration of Autologous CAR-T CD19 Antigen With Inducible Safety Switch in Patients With Relapsed/Refractory ALL
The body has different ways of fighting infection and disease. No single way is effective at fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells.
- Conditions
- Acute Lymphoblastic Leukemia, Immune System Diseases, Immunoproliferative Disorders
- Trial name
- NCT03016377
- Testing
- iC9-CAR19 cells, Rimiducid, Cyclophosphamide
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL), Relapsed/Refractory Non-Hodgkin Lymphoma
NexCAR19 (Talikabtagene Autoleucel) in Relapsed/Refractory B-Cell Malignancies (NexCAR19)
The NexCAR19 study is a national, open-label, multicenter Phase 2-3 clinical trial designed to evaluate the efficacy and safety of the anti-CD19 chimeric antigen receptor (CAR) T-cell product, Talikabtagene Autoleucel, in…
- Conditions
- Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL), Relapsed/Refractory Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma (DLBCL), High-grade B-cell Lymphoma (HGBCL)
- Trial name
- NexCAR19 (NCT07502118)
- Testing
- Talikabtagene Autoleucel
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Health Institutes of Turkey
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
CAR T-Cell Therapy
Neuroimaging and Biomarkers of Neurotoxicity After Chimeric Antigen Receptor T-Cell Therapy
The goal of this study is to understand why some people receiving chimeric antigen receptor (CAR) T-cell therapy for cancer experience neurotoxicity.
- Trial name
- NCT07075523
- Testing
- Brain magnetic resonance imaging, neurocognitive assessments, quality of life questionnaire, biomarkers
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of California, San Diego
Myeloma, Lymphoma
PRONTO Trial (PRophylactic Versus ON-demand Use of TOcilizumab)
Despite the consequent use of Tocilizumab together with conventional antipyretics at early/first signs of emerging CRS, CRS (and eventually the subsequent development of ICANS) remain a major concern for patients.
- Conditions
- Myeloma, Lymphoma, Leukemia
- Trial name
- PRONTO (NCT06430736)
- Testing
- Tocilizumab before CAR-T cell infusion, Tocilizumab at emerging CRS
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
CAR T Cell Therapy, ICANS
Neurological and Cognitive Dysfunction Following CAR-T Treatment. ICANS and Beyond
This is a phase 4 non-interventional single center trial. We aim to prospectively include patients scheduled to undergo CAR-T therapy at ME CAST, Karolinska University Hospital Huddinge, to study ICANS.
- Conditions
- CAR T Cell Therapy, ICANS, Cognitive and Executive Dysfunction
- Trial name
- NCT07375628
- Volunteers
- 10 people
- Sponsor
- Karolinska University Hospital
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
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
Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma
Natalizumab for the Prevention of ICANS in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma Receiving CAR T-Cell Therapy
This phase II studies how well natalizumab works in preventing immune effector cell associated neurologic syndrome (ICANS) in patients with diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL) that has come back…
- Conditions
- Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Mantle Cell Lymphoma
- Trial name
- NCT07892027
- Testing
- Axicabtagene Ciloleucel, Biospecimen Collection, Brexucabtagene Autoleucel
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- University of Michigan Rogel Cancer Center
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