BHB & CAR-T for Lymphomas

Not Applicable

Recruiting

• Conditions: Large B-cell Lymphoma
• Interventions: Dietary Supplement: R-1,3-Butanediol

• Registration Number: NCT06610344
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-24
• Study Start: 2025-01-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-10-15
• Study Completion: 2026-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	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 Outcome Measures

Name	Time	Method
Changes in gut microbiome	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
Changes in peripheral blood mononuclear cells	prior to BHB administration to day 28 visit after CART	compare changes in number and phenotype using flow cytometry, single cell RNAseq, qPCR

Trial Locations

Locations (1)

Abramson Cancer Center at University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States