The aim of this study is to assess the feasibility of β-hydroxybutyrate (BHB) supplementation in individuals who are receiving therapy for lymphoma with standard-of-care anti-CD19 CAR T-cells (CAR-T) to determine whether BHB supplementation is safe and tolerable in this patient population. Additionally, this study will determine whether BHB supplementation leads to changes the gut microbiome and peripheral blood mononuclear cells (PBMCs). BHB supplementation will be performed through oral administration of HVMN Ketone-IQ, a commercially available BHB supplement, with an active ingredient of R- 1,3-Butanediol, which is converted to BHB.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
R-1,3-Butanediol 35 mL
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGSafety and tolerability
Assess number and severity of adverse events as well as number of patients who complete treatment
Time frame: From CART infusion to day 28 visit after CART
Changes in gut microbiome
compare changes in stool microbiome diversity assessed by stool 16S rRNA gene sequencing, metabolomics, qPCR
Time frame: prior to BHB administration to day 28 visit after CART
Changes in peripheral blood mononuclear cells
compare changes in number and phenotype using flow cytometry, single cell RNAseq, qPCR
Time frame: prior to BHB administration to day 28 visit after CART
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