Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05702853
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2022-12-07
Brief Title:
Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19 RelapsedRefractory NHL CLLSLL
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Phase 1b Dose Escalation Study of Metabolically Fit CD19 Chimeric Antigen Receptor CAR T Cells With CD34 Selection Markers in Adult Patients With Relapsed or Refractory CD19 B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center nonrandomized open-label dose-escalation study followed by dose-expansion of CD19- CD34t metabolically programmed CAR T-cell therapy in adult patients with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma NHL or chronic lymphocytic leukemia CLLsmall lymphocytic lymphoma SLL
Detailed Description:
Although CD19 CAR T-cell therapy is a dynamic scientific and clinical breakthrough for CD19 NHL issues still remain in terms of relapse toxicity and availability This trial will incorporate a CD34 tag CD34t into the CAR T-cell construct thus allowing a more purified CAR T-cell product via CD34 selection This purification step will hopefully lead to an improvement in safetytoxicity Furthermore the issue of CD19 CAR T-cell relapse has been linked to a lack of CAR T-cell fitness With the knowledge that Th1 T-cell subsets have improved effector function and Th17 T-cell subsets have improved persistence the investigators plan to expose the collected T-cells to priming conditions that lead to a metabolically enhanced CAR-T cell product akin to a Th117 hybrid cell The investigators hypothesize that these metabolically programmed CD19 CAR-T cells will yield a high- quality product with enhanced persistence and anti-tumor efficacy when purified based on CD34t expression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None