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NCT Number: NCT06610344

BHB & CAR-T for Lymphomas

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 available for the duration of the study

Exclusion criteria

  • Subject is pregnant or breast feeding
  • History of allergy to energy drinks
  • History of inflammatory bowel disease
  • History of type 1 diabetes mellitus or requirement for insulin
  • History of chronic kidney disease with an eGFR < 30 mL/min/1.73m2
  • Additional second primary malignancy for which the subject is receiving active therapy or that will impede the ability of the investigator to assess lymphoma response

Treatment and study plan

R-1,3-Butanediol

Dietary Supplement

R-1,3-Butanediol 35 mL

Other names: Ketone

Primary outcomes

  1. Safety and tolerability

    Time frame: From CART infusion to day 28 visit after CART

    Assess number and severity of adverse events as well as number of patients who complete treatment

Secondary outcomes

  1. Changes in gut microbiome

    Time frame: prior to BHB administration to day 28 visit after CART

    compare changes in stool microbiome diversity assessed by stool 16S rRNA gene sequencing, metabolomics, qPCR

  2. Changes in peripheral blood mononuclear cells

    Time frame: prior to BHB administration to day 28 visit after CART

    compare changes in number and phenotype using flow cytometry, single cell RNAseq, qPCR

Study contacts

Contact information is provided by the study sponsor or research team.

Brittany Koch, MPH

CONTACT

[email protected]

215-615-4312

Kaitlin Kennard, BSN, RN

CONTACT

[email protected]

267-804-4080

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Preliminary Investigation of β-hydroxybutyrate Supplementation for Lymphoma Patients Receiving Anti-CD19 CAR T-cells

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 24, 2024
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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