BHB & CAR-T for Lymphomas

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT06610344
Status
Recruiting
Apply to this trial

Conditions

  • Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • R-1,3-Butanediol — DIETARY_SUPPLEMENT
    R-1,3-Butanediol 35 mL

Study Details

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.

Key Dates

Start date
Jan 7, 2025
Status verified
Feb 2026
Primary completion
Sep 15, 2026
Completion
Sep 15, 2027

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R-1,3-Butanediol
    Participants will take 35mL of HVMN Ketone-IQ by mouth three times daily, with each dose containing 10 grams of R-1,3-Butanediol.

Primary Outcome Measure

Safety and tolerability [ Time Frame: From CART infusion to day 28 visit after CART ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center at University of PennsylvaniaPhiladelphiaPennsylvania19104
Brittany Koch, MPH
[email protected]
215-615-4312
Kaitlin Kennard, BSN, RN
[email protected]
267-804-4080

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