Preliminary Investigation of β-hydroxybutyrate Supplementation for Lymphoma Patients Receiving Anti-CD19 CAR T-cells
Abramson Cancer Center at Penn Medicine
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age of 18 years or older * History of pathologically-confirmed large B-cell lymphoma (LBCL) * Planned treatment with a commercially available anti-CD19 CAR-T product (Yescarta or Kymriah) * Eligible for and with adequate organ function (investigator discretion) and performance status (ECOG PS 2 or less) for standard of care, anti-CD19 CAR-T * Not enrolled on a clinical trial of bridging therapy prior to CAR-T * Patients must have a PET/CT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesions or ≥ 1cm…
Interventions
- Dietary SupplementR-1,3-Butanediol
R-1,3-Butanediol 35 mL
Location
- Abramson Cancer Center at University of PennsylvaniaPhiladelphia, Pennsylvania