Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522932
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIb PET Imaging Study of 64Cu-GRIP B a Radiotracer Targeting Granzyme B in Patients Receiving CD19-directed CAR-T Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This is a phase IIb imaging study of granzyme B 64-copper granzyme targeting restricted interaction peptide specific to family member B 64Cu-GRIP B Positron Emission Tomography PET in patients with relapsedrefractory non-Hodgkins lymphoma NHL receiving CD19-directed Chimeric antigen receptor T cells CAR-T therapy The proposed study represents the first-ever lymphoma patient imaging studies with 64Cu-GRIP B PET The tracer is designed to detect extracellular granzyme B as it is secreted by activated immune cells in the tumor microenvironment which may highlight tumors that will exhibit a durable response to Cluster of Differentiation 19 CD19-directed CAR T-cell therapy
Detailed Description:
Primary Objectives
1 To establish the feasibility of granzyme B detection with 64Cu-GRIP B PET in participants with relapsedrefractory NHL receiving CD19-directed CAR-T cell therapy in both cohorts
Secondary Objectives
1 To descriptively report the patterns of intra-tumoral uptake of 64Cu-GRIP B on whole body PET including by site of disease uptake by tumor type inter-tumoral and inter-participant heterogeneity and tumor-to-background signal in participants with participants with NHL
2 To descriptively report the number of lesions identified on 64Cu-GRIP B PET compared with conventional imaging in participants with NHL
3 To assess the safety of 64Cu-GRIP B in participants with NHL undergoing CAR-T cell therapy
Participants will be initially enrolled in Cohort 1 Based on the interim analysis enrollment will begin in Cohort 2 An optional research biopsy will be collected after the post-therapy scan and participants will be followed for 12 months after the end of the study intervention
1 To establish the feasibility of granzyme B detection with 64Cu-GRIP B PET in participants with relapsedrefractory NHL receiving CD19-directed CAR-T cell therapy in both cohorts
Secondary Objectives
1 To descriptively report the patterns of intra-tumoral uptake of 64Cu-GRIP B on whole body PET including by site of disease uptake by tumor type inter-tumoral and inter-participant heterogeneity and tumor-to-background signal in participants with participants with NHL
2 To descriptively report the number of lesions identified on 64Cu-GRIP B PET compared with conventional imaging in participants with NHL
3 To assess the safety of 64Cu-GRIP B in participants with NHL undergoing CAR-T cell therapy
Participants will be initially enrolled in Cohort 1 Based on the interim analysis enrollment will begin in Cohort 2 An optional research biopsy will be collected after the post-therapy scan and participants will be followed for 12 months after the end of the study intervention
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