| NCT ID | NCT06610344 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | Large B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2025-01-07 |
| Primary Completion | 2026-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2025-01-07 with a primary completion date of 2026-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Elise Chong, MD
PRINCIPAL INVESTIGATOR
Abramson Cancer Center at the University of Pennsylvania
Frequently Asked Questions
Who can join the NCT06610344 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Large B-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06610344 currently recruiting?
Yes, NCT06610344 is actively recruiting participants. Contact the research team at Brittany.Koch@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06610344 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06610344 clinical trial?
NCT06610344 is sponsored by Abramson Cancer Center at Penn Medicine. The principal investigator is Elise Chong, MD at Abramson Cancer Center at the University of Pennsylvania. The trial plans to enroll 5 participants.