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

NCT06522932 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • Non Hodgkin Lymphoma

Interventions

DRUG

64Cu-GRIP B

Given IV

PROCEDURE

Positron Emission Tomography (PET)

Undergo imaging procedure

PROCEDURE

Optional tumor biopsy

Undergo optional tumor biopsy

Sponsors & Collaborators

  • The V Foundation

    collaborator OTHER

  • Michael Randall

    lead OTHER

Principal Investigators

  • Randall Michael, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-23
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06522932 on ClinicalTrials.gov