RecruitingNot ApplicableNCT06610344

BHB & CAR-T for Lymphomas

Preliminary Investigation of β-hydroxybutyrate Supplementation for Lymphoma Patients Receiving Anti-CD19 CAR T-cells

Sponsor

Abramson Cancer Center at Penn Medicine

Enrollment

5 participants

Start Date

Jan 7, 2025

Study Type

INTERVENTIONAL

Conditions

Large B-cell Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a natural compound called beta-hydroxybutyrate (BHB) — produced by the body during fasting or a ketogenic diet — can improve the effectiveness and reduce toxicities of CAR-T cell therapy for large B-cell lymphoma (an aggressive blood cancer). Participants will take BHB supplements alongside their planned CAR-T treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with large B-cell lymphoma - You are planning to receive CAR-T cell therapy (Yescarta or Kymriah) as part of your standard care - You are in adequate health to receive CAR-T therapy - You have at least one measurable tumor on imaging **You may NOT be eligible if...** - You are already enrolled in a clinical trial for bridging therapy before CAR-T - You have not resolved toxicities from previous treatments - You are not eligible for standard-of-care CAR-T Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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