---
title: BHB & CAR-T for Lymphomas
nct_id: NCT06610344
overall_status: RECRUITING
phase: NA
sponsor: Abramson Cancer Center at Penn Medicine
study_type: INTERVENTIONAL
primary_condition: Large B-cell Lymphoma
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06610344.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06610344"
ct_last_update_post_date: 2026-02-23
last_seen_at: "2026-05-12T07:22:06.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# BHB & CAR-T for Lymphomas

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

**NCT ID:** [NCT06610344](https://clinicaltrials.gov/study/NCT06610344)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 5
- **Lead Sponsor:** Abramson Cancer Center at Penn Medicine
- **Conditions:** Large B-cell Lymphoma
- **Start Date:** 2025-01-07
- **Completion Date:** 2027-09-15
- **CT.gov Last Update:** 2026-02-23

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **R-1,3-Butanediol** (EXPERIMENTAL) — Participants will take 35mL of HVMN Ketone-IQ by mouth three times daily, with each dose containing 10 grams of R-1,3-Butanediol.

## Interventions

- **R-1,3-Butanediol** (DIETARY_SUPPLEMENT) — R-1,3-Butanediol 35 mL

## Primary Outcomes

- **Safety and tolerability** _(time frame: From CART infusion to day 28 visit after CART)_ — Assess number and severity of adverse events as well as number of patients who complete treatment

## Secondary Outcomes

- **Changes in gut microbiome** _(time frame: prior to BHB administration to day 28 visit after CART)_
- **Changes in peripheral blood mononuclear cells** _(time frame: prior to BHB administration to day 28 visit after CART)_

## Locations (1)

- Abramson Cancer Center at University of Pennsylvania, Philadelphia, Pennsylvania, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.abramson cancer center at university of pennsylvania|philadelphia|pennsylvania|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06610344.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06610344*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*