A Phase 1 Clinical Trial Combining CAR T-Cell Therapy with Autologous Hematopoietic Stem Cells in a Multi-Cultural Patient Population
Location
LSU Health New Orleans Human Development Center
Event Website
https://publichealth.lsuhsc.edu/honorsday/2023/
Start Date
1-4-2023 9:00 AM
End Date
2023 3:00 PM
Description
Background: Chimeric Antigen Receptor (CAR) T-Cell therapy is a type of immunotherapy designed to treat relapsed/refractory hematologic malignancies such non-Hodgkin B-Cell Lymphoma, B-Cell Acute Lymphoblastic Leukemia, and Multiple Myeloma. CAR T toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome and post-infusion cytopenias pose major challenges to the regimen. Additionally, CAR T is a complicated and involved therapy. It is critical to explain the risks and benefits to patients, which can be challenging when they are non-native English speakers.
Objectives: The co-primary endpoints of this trial are to determine the feasibility of collecting the target cell dose of autologous hematopoietic stem cells (aHSCs) in 50% of the patients and the safety of combining aHSCs to the planned CAR T treatment. Additionally, we aimed to create educational, multilingual documents to improve patient comprehension of the trial.
Methods: We designed a phase I, single arm clinical trial at Cedars Sinai Medical Center in Los Angeles, California combining aHSCs and any FDA approved CAR T-cell therapy. The aHSC boost should raise blood cell counts, including myeloid cells, which have been shown to work in concert with CAR T-cells in animal models, improving therapeutic efficacy. To address knowledge gaps and language barriers for the local patient population, we created an informed consent form in English and Spanish, created a flow chart describing the procedure in simple terms, and created educational materials for patients explaining the science behind CAR T-cell therapy.
Results: In February of 2023, Cedars Sinai approved the trial with internal funding. It will be activated in the coming months.
Conclusions/Recommendations: We hope our trial will provide meaningful benefit to patients by reducing CAR T related toxicities. Additionally, through our educational content and multilingual consent forms, we aim to increase patient access to and comprehension of this clinical trial.
Recommended Citation
Reinhardt, Bry MS, "A Phase 1 Clinical Trial Combining CAR T-Cell Therapy with Autologous Hematopoietic Stem Cells in a Multi-Cultural Patient Population" (2023). School of Public Health Delta Omega Honors Day Poster Sessions. 12.
https://digitalscholar.lsuhsc.edu/dohd/2023/2023/12
A Phase 1 Clinical Trial Combining CAR T-Cell Therapy with Autologous Hematopoietic Stem Cells in a Multi-Cultural Patient Population
LSU Health New Orleans Human Development Center
Background: Chimeric Antigen Receptor (CAR) T-Cell therapy is a type of immunotherapy designed to treat relapsed/refractory hematologic malignancies such non-Hodgkin B-Cell Lymphoma, B-Cell Acute Lymphoblastic Leukemia, and Multiple Myeloma. CAR T toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome and post-infusion cytopenias pose major challenges to the regimen. Additionally, CAR T is a complicated and involved therapy. It is critical to explain the risks and benefits to patients, which can be challenging when they are non-native English speakers.
Objectives: The co-primary endpoints of this trial are to determine the feasibility of collecting the target cell dose of autologous hematopoietic stem cells (aHSCs) in 50% of the patients and the safety of combining aHSCs to the planned CAR T treatment. Additionally, we aimed to create educational, multilingual documents to improve patient comprehension of the trial.
Methods: We designed a phase I, single arm clinical trial at Cedars Sinai Medical Center in Los Angeles, California combining aHSCs and any FDA approved CAR T-cell therapy. The aHSC boost should raise blood cell counts, including myeloid cells, which have been shown to work in concert with CAR T-cells in animal models, improving therapeutic efficacy. To address knowledge gaps and language barriers for the local patient population, we created an informed consent form in English and Spanish, created a flow chart describing the procedure in simple terms, and created educational materials for patients explaining the science behind CAR T-cell therapy.
Results: In February of 2023, Cedars Sinai approved the trial with internal funding. It will be activated in the coming months.
Conclusions/Recommendations: We hope our trial will provide meaningful benefit to patients by reducing CAR T related toxicities. Additionally, through our educational content and multilingual consent forms, we aim to increase patient access to and comprehension of this clinical trial.
https://digitalscholar.lsuhsc.edu/dohd/2023/2023/12