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RECRUITING
NCT06522932
PHASE1

PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy

Sponsor: Michael Randall

View on ClinicalTrials.gov

Summary

This is a phase I/Ib 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 relapsed/refractory non-Hodgkin's 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.

Official title: A Phase I/Ib PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in Patients Receiving CD19-directed CAR-T Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2024-10-23

Completion Date

2027-01-31

Last Updated

2025-12-29

Healthy Volunteers

Yes

Interventions

DRUG

64Cu-GRIP B

Given IV

PROCEDURE

Positron Emission Tomography (PET)

Undergo imaging procedure

PROCEDURE

Optional tumor biopsy

Undergo optional tumor biopsy

Locations (1)

University of California, San Francisco

San Francisco, California, United States