A Dietary Supplement (HVMN Ketone-IQ) for Treating Patients with B-cell Non-Hodgkin Lymphoma Receiving Anti-CD19 CAR T-Cells

Inclusion Criteria

• Age of 18 years or older
• History of pathologically-confirmed B-cell non-Hodgkin lymphoma (LB-NHL)
• Planned treatment with a commercially available, standard of care anti-CD19 CAR-T product
• Eligible for and with adequate organ function (investigator discretion) and performance status (Eastern Cooperative Oncology Group (ECOG) performance status [PS] 2 or less) for standard of care, anti-CD19 CAR-T
• Not enrolled on a clinical trial in which an investigational product is administered concurrently with CAR T cell therapy
• 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 extranodal lesions in largest dimension by low-dose computerized tomography [CT] scan with fluorodeoxyglucose [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
• Active gastrointestinal pathology that may interfere with either ingestion of supplement or supplement absorption; or, patients who are unable to take a liquid supplement
• History of type 1 diabetes mellitus or requirement for insulin
• Additional second primary malignancy that will impede the ability of the investigator to assess toxicity or lymphoma response
• Use of either a ketogenic diet or intermittent fasting (defined as a fasting period of 16 hours or more per day that is not associated with a medical procedure) during the 4 weeks prior to enrollment
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment that is not adequately controlled to safely receive CAR-T infusion
• Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results