A Phase I/Ib PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in Patients Receiving CD19-directed CAR-T Therapy
Michael Randall
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.
Description
Primary Objectives: 1\. To establish the feasibility of granzyme B detection with 64Cu-GRIP B PET in participants with relapsed/refractory 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 con…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Disease characteristics, as defined by: 1. Histologically-confirmed relapsed/refractory non-Hodgkin lymphoma (NHL) with at least one prior line of therapy. 2. Planned treatment with a commercially available CD19 targeting CAR-T cell product. 2. Willing to undergo post-treatment tumor biopsies and has safely accessible soft tissue lesion. 3. Age \>= 18 years. 4. Ability to understand and the willingness to sign a written informed consent document. 5. Eastern Cooperative Oncology Group (ECOG) performance status \<2 (Karnofsky \>60%). 6. Individuals with treated bra…
Interventions
- Drug64Cu-GRIP B
Given IV
- ProcedurePositron Emission Tomography (PET)
Undergo imaging procedure
- ProcedureOptional tumor biopsy
Undergo optional tumor biopsy
Location
- University of California, San FranciscoSan Francisco, California