BHB & CAR-T for Lymphomas | NCT06610344

Studies
BHB & CAR-T for Lymphomas

NCT06610344

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Recruiting

Last Update Posted

Feb 23, 2026Actual

Enrollment

5Estimated

Phase

Not Applicable

Conditions

Large B-cell Lymphoma

Interventions

R-1,3-Butanediol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB#856611	Other Identifier	University of Pennsylvania IRB

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2025Actual

Primary Completion Date

Sep 15, 2026Estimated

Completion Date

Sep 15, 2027Estimated

First Submitted Date

Sep 20, 2024

First Submission Date that Met QC Criteria

Sep 20, 2024

First Posted Date

Sep 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2026

Last Update Posted Date

Feb 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
R-1,3-Butanediol	Dietary Supplement	R-1,3-Butanediol 35 mL	R-1,3-Butanediol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Changes in gut microbiome	compare changes in stool microbiome diversity assessed by stool 16S rRNA gene sequencing, metabolomics, qPCR	prior to BHB administration to day 28 visit after CART
Changes in peripheral blood mononuclear cells

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Brittany Koch, MPH	Contact	215-615-4312		Brittany.Koch@pennmedicine.upenn.edu
Kaitlin Kennard, BSN, RN	Contact	267-804-4080		Kaitlin.Kennard@pennmedicine.upenn.edu

Overall Officials

Name	Affiliation	Role
Elise Chong, MD	Abramson Cancer Center at the University of Pennsylvania	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abramson Cancer Center at University of Pennsylvania	Recruiting	Philadelphia	Pennsylvania	19104	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

It is not yet known if there will be a plan to make IPD available. Explanation: currently under discussion regarding logistics of sharing, data to be shared, and how to access. Some IPD, likely CSR, will be shared after publication. We will finalize a plan by 3/2025

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
C574168	beta-hydroxybutyrate-1,3-butanediol monoester
D007659	Ketones