Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610344
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
BHB CAR-T for Lymphomas
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Preliminary Investigation of β-hydroxybutyrate Supplementation for Lymphoma Patients Receiving Anti-CD19 CAR T-cells
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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- 13-Butanediol which is converted to BHB
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None