TheranosticTrials.org

Clinical Trial · NCT06522932

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

Overview

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.

Sponsor

University of California, San Francisco

Phase

Phase 1

Contacts

Randall Michael, MD (PRINCIPAL_INVESTIGATOR)

UCSF Hematopoietic Malignancies Clinical Trial Recruitment (CONTACT)

hdfccc.heme@ucsf.edu

877-827-3222

ClinicalTrials.gov

NCT06522932

Drug / Compound

GRIP B

Isotope(s):
Target(s):
  • Granzyme B
Ligand Class: Small Proteins and Antibody Fragments

Eligibility

Inclusion

  • 1. Disease characteristics, as defined by:
  • Age \>= 18 years.
  • Histologically-confirmed relapsed/refractory non-Hodgkin lymphoma (NHL) with at least one prior line of therapy.
  • Planned treatment with a commercially available CD19 targeting CAR-T cell product.
  • Willing to undergo post-treatment tumor biopsies and has safely accessible soft tissue lesion.

Exclusion

  • 1. Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures.
  • Hypersensitivity to 64Cu-GRIP B or any of its excipients.
  • Pregnant participants are excluded from this study because the effects of 64Cu-GRIP B on the developing human fetus are unknown. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing parent with 64Cu-GRIP B, breastfeeding should be discontinued if the nursing parent receives 64Cu-GRIP B.