BHB & CAR-T for Lymphomas

Abramson Cancer Center at Penn Medicine

Status: Enrolling

Conditions: Large B-cell Lymphoma

Treatments: Dietary Supplement: R-1,3-Butanediol

Study type: Interventional

Funder types: Other

Identifiers

NCT06610344

UPCC 41424

IRB#856611 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

R-1,3-Butanediol

Experimental group

Description:

Participants will take 35mL of HVMN Ketone-IQ by mouth three times daily, with each dose containing 10 grams of R-1,3-Butanediol.

Treatment:

Dietary Supplement: R-1,3-Butanediol