Preliminary Investigation of β-hydroxybutyrate Supplementation for Lymphoma Patients Receiving Anti-CD19 CAR T-cells
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: R-1,3-Butanediol (Dietary Supplement)
结局指标
主要结局
Safety and tolerability
时间窗: 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
次要结局
- Changes in gut microbiome(prior to BHB administration to day 28 visit after CART)
- Changes in peripheral blood mononuclear cells(prior to BHB administration to day 28 visit after CART)