The purpose of this prospective and observational study is to evaluate the correlation between gut microbiota and clinical response to CAR-T treatment for hematological malignancies
Chimeric antigen receptor T-cell (CAR-T) therapy has shown impressive efficacy in hematological malignancies. However, response rates and associated immune-related adverse effects widely vary among patients. And no biomarkers have been identified to predict the efficacy and associated toxicities after CAR-T therapy in patients. Several preclinical experiments and clinical studies have shown that gut microbiota was associated with the efficacy of T cell-driven cancer immunotherapies and their toxicities. In hematologic malignancies, gut microbiota was associated with the development of graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the potential correlation between gut microbiota and the effificacy and toxicity of CAR-T therapy is unclear. Therefore, in this study, we aim to evaluate the correlation between gut microbiota and clinical response to CAR-T treatment for hematological malignancies.
Study Type
OBSERVATIONAL
Enrollment
100
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGgut microbiota
diversity and composition of the gut microbiota
Time frame: From pre-lymphodepletion regimen to day 28 after CAR-T cells infusion
efficacy of CAR-T therapy
CR,PR and NR
Time frame: six months
toxicity of CAR-T therapy
Adverse events are evaluated with CTCAE V5.0
Time frame: six months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.