Who is eligible for clinical trial NCT06610344?

Participants must meet protocol criteria for Large B-cell Lymphoma. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06610344 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-02-20

BHB & CAR-T for Lymphomas (NCT06610344)

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Abramson Cancer Center at Penn Medicine

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (7 items).

Location: Abramson Cancer Center at University of Pennsylvania — Philadelphia, Pennsylvania

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Abramson Cancer Center at University of Pennsylvania — Philadelphia, Pennsylvania

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗