Event Website
https://publichealth.lsuhsc.edu/honorsday/2023/
Start Date
1-4-2024 9:00 AM
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, "A Phase 1 Clinical Trial Combining CAR T-Cell Therapy with Autologous Hematopoietic Stem Cells in a Multi-Cultural Patient Population" (2024). 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
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