Clinical trial NCT06610344: BHB & CAR-T for Lymphomas
Official title: Preliminary Investigation of Β-hydroxybutyrate Supplementation for Lymphoma Patients Receiving Anti-CD19 CAR T-cells
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Large B-cell Lymphoma
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Safety and tolerability
timeFrame: From CART infusion to day 28 visit after CART
Secondary outcomes:
measure: Changes in gut microbiome
timeFrame: prior to BHB administration to day 28 visit after CART
measure: Changes in peripheral blood mononuclear cells
timeFrame: prior to BHB administration to day 28 visit after CART
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center at University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at the University of Pennsylvania
name: Elise Chong, MD
role: PRINCIPAL_INVESTIGATOR
References: