BHB & CAR-T for Lymphomas

This study is looking at whether adding a dietary supplement called R-1,3-Butanediol (which turns into BHB in your body) is safe and can be tolerated by people with large B-cell lymphoma (LBCL). You could be eligible if you are 18 or older, have LBCL, and are planning to receive standard CAR-T cell therapy (Yescarta or Kymriah). The main goal is to see if R-1,3-Butanediol is safe and tolerable when given with CAR-T therapy. The study will also look at how this supplement might affect your gut bacteria and blood cells. The current status of this study is unclear, and it plans to enroll 5 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 5 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured from CAR-T infusion to day 28 after CAR-T.

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NCT06610344

BHB & CAR-T for Lymphomas

Recruiting
NAAges 18+InterventionalTreatment
Abramson Cancer Center at Penn Medicine
~5 participants
Updated 2026-02-23 on ClinicalTrials.gov
What's tested:R-1,3-Butanediol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability
Measured over From CART infusion to day 28 visit after CART
Large B-cell Lymphoma
1 sites across 1 states
Pennsylvania1
  • Elise Chong, MD · PRINCIPAL_INVESTIGATOR · Abramson Cancer Center at the University of Pennsylvania

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Eligibility criteria

Inclusion

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

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
  • Safety and tolerabilityFrom CART infusion to day 28 visit after CART

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