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

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

NCT ID: NCT06522932

Condition: Non Hodgkin Lymphoma

Conditions: Official terms:
Lymphoma, Non-Hodgkin
Copper

Conditions: Keywords:
CAR-T therapy
Imaging

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 64Cu-GRIP B
Description: Given IV
Arm group label: Cohort 1: 64Cu-GRIP B PET imaging
Arm group label: Cohort 2: Expansion Phase 64Cu-GRIP B PET imaging

Other name: granzyme B, 64-copper granzyme targeting restricted interaction peptide specific to family member B

Intervention type: Procedure
Intervention name: Positron Emission Tomography (PET)
Description: Undergo imaging procedure
Arm group label: Cohort 1: 64Cu-GRIP B PET imaging
Arm group label: Cohort 2: Expansion Phase 64Cu-GRIP B PET imaging

Other name: PET Scan

Intervention type: Procedure
Intervention name: Optional tumor biopsy
Description: Undergo optional tumor biopsy
Arm group label: Cohort 1: 64Cu-GRIP B PET imaging
Arm group label: Cohort 2: Expansion Phase 64Cu-GRIP B PET imaging

Other name: Biopsy

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.

Detailed 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 conventional imaging in participants with NHL. 3. To assess the safety of 64Cu-GRIP B in participants with NHL undergoing CAR-T cell therapy. Participants will be initially enrolled in Cohort 1. Based on the interim analysis, enrollment will begin in Cohort 2. An optional research biopsy will be collected after the post-therapy scan and participants will be followed for 12 months after the end of the study intervention.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Disease characteristics, as defined by: 1. Histologically-confirmed relapsed/refractory non-Hodgkin lymphoma 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. Demonstrates adequate organ function as defined below: 1. Absolute neutrophil count >=1,500/microliter (mcL) 2. Platelets ≥100,000/mcL 3. Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits. 4. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) <=3 X institutional upper limit of normal. 5. Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) <=3 X institutional upper limit of normal 6. Creatinine <= 1.5 x within institutional upper limit of normal OR creatinine clearance Glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2. 7. Human immunodeficiency virus (HIV)-infected individuals on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial. 8. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 9. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. Individuals with HCV infection who are currently on treatment are eligible if an undetectable HCV viral load is demonstrated. 10. Individuals with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. 11. Individuals with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy. 12. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. The effects of 64Cu-GRIP B on the developing human fetus are unknown. For this reason, participants of childbearing potential must agree to use adequate contraception: all participants should use barrier protection for the duration of study participation and for one month after last administration of study intervention. Should a participant become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Male participants treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and one month after last administration of study treatment. Exclusion Criteria: 1. Any condition that, in the opinion of the Principal Investigator, would impair the participant's ability to comply with study procedures. 2. 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. 3. Hypersensitivity to 64Cu-GRIP B or any of its excipients.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: University of California, San Francisco

Address:
City: San Francisco
Zip: 94143
Country: United States

Status: Recruiting

Contact:
Last name: Lily Ju
Email: lily.ju@ucsf.edu

Contact backup:

Phone: 877-827-3222
Email: cancertrials@ucsf.edu

Contact backup:
Last name: C. Babis Andreadis, MD

Start date: October 30, 2024

Completion date: January 31, 2027

Lead sponsor:
Agency: C. Babis Andreadis
Agency class: Other

Collaborator:
Agency: The V Foundation
Agency class: Other

Source: University of California, San Francisco

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06522932