NCT06610344 BHB & CAR-T for Lymphomas

Trial Parameters

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Brief 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 Criteria

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 for extra- nodal lesions in largest dimension by low-dose computerized tomography \[CT\] scan with FDG-uptake ≥ liver) documented prior to leukapheresis for CAR-T manufacturing * Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator * Can provide informed consent * Willing to comply with all study procedures and a

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