UPCC 41424 Preliminary Investigation of β-Hydroxybutyrate Supplementation for Lymphoma Patients Receiving Anti-CD19 CAR T-Cells (BHB & CAR-T for Lymphomas)
Safety of β-Hydroxybutyrate Supplementation in Lymphoma Patients Undergoing CAR T-Cell Therapy
Brief description of study
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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Large B-cell Lymphoma
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Age: 18 years or above
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Gender: All
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
This study investigates the safety and tolerability of β-hydroxybutyrate (BHB) supplementation in patients receiving standard-of-care anti-CD19 CAR T-cells for the treatment of lymphoma. The purpose of this study is to determine if BHB supplementation, administered orally, affects the gut microbiome and peripheral blood mononuclear cells (PBMCs) in these patients.
Participants will take BHB through a commercially available supplement called HVMN Ketone-IQ, which contains the active ingredient R-1,3-Butanediol. This ingredient is converted to BHB in the body. The study will monitor changes in the gut microbiome and PBMCs to assess the effects of BHB supplementation.
- Who can participate: Participants must be 18 years or older with a confirmed diagnosis of large B-cell lymphoma and planning to receive anti-CD19 CAR-T therapy. They should have adequate organ function and performance status, and not be enrolled in a bridging therapy trial.
- Study details: Participants will take an oral supplement of BHB during the study. They must be willing to comply with all study procedures and be available for the study duration.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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