Non-Hodgkin's Lymphoma
Conditions
Brief summary
This is a pilot study in adult subjects with aggressive B-cell lymphoma who will receive commercial or research CAR T cell therapy as anticancer treatment.
Detailed description
Primary Objectives: \* Explore the relationship of change in \[18F\]F-AraG PET signal following CAR T cell treatment with changes in T cell infiltration in tumor biopsies. Exploratory Analyses: * Explore the relationship of change in \[18F\]F-AraG PET signal in tumor lesions following CAR T cell treatment with clinical benefit rate (defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) ≥ 3 months) using RECISTv1.1 criteria * Correlate the change in \[18F\]F-AraG PET signal in tumor lesions following CAR T cell therapy with maximum grade of Cytokine Release Syndrome (CRS) and neurotoxicity experienced.
Interventions
DRUG[ 18F]F-AraG PET
Dose: 5 mCi (±10%) Mode of Administration: Intravenous (IV)
Sponsors
CellSight Technologies, Inc.
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2008: * DLBCL not otherwise specified; T cell/histiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR * primary mediastinal (thymic) large B cell lymphoma * transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia to DLBCL will also be included * Measurable disease by PET imaging (as defined by Cheson (2014)), that meets all the following criteria: * At least one measureable lesion away from head & neck, liver, kidneys, GI tract and bladder * At least one biopsy-accessible lesion or lymph node. * Express willingness to undergo low risk FNA or core biopsy of subcutaneous accessible lesion or lymph node. * Scheduled to receive commercial or research CAR T cell therapy with axicabtagene ciloleucel (Yescarta ®) as part of anticancer therapy. * Adequate renal and hepatic function, defined as: 1. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min or Cr \< 1.6 mg/dL 2. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5x upper limit of normal (ULN) 3. Total bilirubin ≤ 1.5 mg/dL, except in cases of Gilbert's syndrome * Able to give informed consent. Subjects unable to give informed consent will not be eligible for this study
Exclusion criteria
* Women who are pregnant or breastfeeding. * Subjects with significant GI disease involvement by PET imaging * In the investigator's judgment, have any medical condition likely to interfere with assessment of safety or efficacy, be unable to tolerate additional radiation, or be unlikely to complete all protocol-required visits and procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome measure | values obtained on Day 0 and Day 4 (± 2 days) | Spearman correlation between changes in SUV in \[18F\]F-AraG signal on PET imaging to changes in T-cell infiltrates in biopsy samples |
Other
| Measure | Time frame | Description |
|---|---|---|
| First exploratory outcome measure | ≥ 3 months | correlation between changes in SUV \[18F\]F-AraG signal on PET imaging to the observed clinical benefit rate using RECISTv1.1 criteria. |
| Second exploratory outcome measure | ≥ 3 months | Correlation between changes in \[18F\]F-AraG signal to the frequency and grade of two common CAR T cell toxicities, cytokine release syndrome (CRS) and neurotoxicity, if observed in this study population. |
Countries
United States
Outcome results
None listed