NCT06610344

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jan 2025Sep 2027

First Submitted

Initial submission to the registry

September 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 7, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

September 20, 2024

Last Update Submit

February 20, 2026

Conditions

Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability

    Assess number and severity of adverse events as well as number of patients who complete treatment

    From CART infusion to day 28 visit after CART

Secondary Outcomes (2)

  • Changes in gut microbiome

    prior to BHB administration to day 28 visit after CART

  • Changes in peripheral blood mononuclear cells

    prior to BHB administration to day 28 visit after CART

Study Arms (1)

R-1,3-Butanediol

EXPERIMENTAL

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

Dietary Supplement: R-1,3-Butanediol

Interventions

R-1,3-ButanediolDIETARY_SUPPLEMENT

R-1,3-Butanediol 35 mL

Also known as: Ketone
R-1,3-Butanediol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Interventions

beta-hydroxybutyrate-1,3-butanediol monoesterKetones

Intervention Hierarchy (Ancestors)

Organic Chemicals

Study Officials

  • Elise Chong, MD

    Abramson Cancer Center at the University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Koch, MPH

CONTACT

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

Kaitlin Kennard, BSN, RN

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2024

First Posted

September 24, 2024

Study Start

January 7, 2025

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2027

Last Updated

February 23, 2026

Record last verified: 2026-02

Locations

US(1)