Recruiting

BHB & CAR-T

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT06610344

Conditions

Large B-cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

R-1,3-Butanediol

Study Details

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.

Conditions

Large B-cell Lymphoma

Study ID

NCT06610344

Start date

Jan 7, 2025

Status verified date

Feb, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Sep 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

R-1,3-Butanediol

R-1,3-Butanediol 35 mL

Primary outcome measure

  • Safety and tolerability [ Time Frame: From CART infusion to day 28 visit after CART ]

Central Contacts and Locations

Central contacts

Brittany Koch, MPH

215-615-4312Brittany.Koch@pennmedicine.upenn.edu

Kaitlin Kennard, BSN, RN

267-804-4080Kaitlin.Kennard@pennmedicine.upenn.edu

Locations

Abramson Cancer Center at University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Brittany Koch, MPH

215-615-4312Brittany.Koch@pennmedicine.upenn.edu

Kaitlin Kennard, BSN, RN

267-804-4080Kaitlin.Kennard@pennmedicine.upenn.edu

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-02-23.