PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy (NCT06522932) | Clinical Trial Compass
RecruitingPhase 1
PET Imaging Study of 64Cu-GRIP B for Patients Receiving CD19-directed CAR-T Therapy
United States32 participantsStarted 2024-10-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Disease characteristics, as defined by:
✓. 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.
✓. Age \>= 18 years.
✓. Ability to understand and the willingness to sign a written informed consent document.
✓. Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%).
✓. Individuals with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
Exclusion criteria
✕. Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures.
What they're measuring
1
Proportion of positive tumors at the post-CAR-T scan
Timeframe: From prior to CAR-T to Day 22 following CAR-T cell, approximately 32 days total
✕. 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.
✕. Hypersensitivity to 64Cu-GRIP B or any of its excipients.