BHB & CAR-T for Lymphomas

NCT ID: NCT06610344

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-07
• Study Completion Date: 2026-10-15

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

R-1,3-Butanediol

Intervention Type: DIETARY_SUPPLEMENT

R-1,3-Butanediol 35 mL

Interventions

R-1,3-Butanediol

R-1,3-Butanediol 35 mL

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Ketone

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elise Chong, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at the University of Pennsylvania

Locations

Abramson Cancer Center at University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brittany Koch, MPH

Role: CONTACT

Brittany.Koch@pennmedicine.upenn.edu

215-615-4312

Kaitlin Kennard, BSN, RN

Role: CONTACT

Kaitlin.Kennard@pennmedicine.upenn.edu

267-804-4080

Facility Contacts

Brittany Koch, MPH

Role: primary

Brittany.Koch@pennmedicine.upenn.edu

215-615-4312

Kaitlin Kennard, BSN, RN

Role: backup

Kaitlin.Kennard@pennmedicine.upenn.edu

267-804-4080

Other Identifiers

IRB#856611

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 41424

Identifier Type: -

Identifier Source: org_study_id