Large B-cell lymphoma lymphoma
Conditions
Interventions
In this imaging trial, the purpose is to explore the feasibility of anti-PD-L1
PET/CT imaging in patients to gain insights into clinically relevant PD-L1
expression in the setting of CD19-directed C
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed LBCL and associated subtypes, defined by WHO 2016 classification 2. Eligibility for CAR T-cell therapy must be approved by the Dutch National Tumor Board. 3. Measurable disease, as defined by Lugano criteria 4. Signed informed consent. 5. Age >=18 at the time of signing informed consent. 6. Ability to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1.Signs or symptoms of active infection within 2 weeks prior to 89Zr-atezolizumab injection, unless treated to resolution. 2.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. 3.Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of 89Zr-atezolizumab, or that may affect the interpretation of the results or render the patient at high risk from complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary parameters - to study the expression of PD-L1 in normal tissue and lymphoma lesions before CD19-directed CAR T-cell therapy in LBCL patients by 89Zr-atezolizumab PET/CT imaging and to correlate pretreatment 89Zr-atezolizumab uptake to response to CD19-directed CAR T-cell therapy and thereby identify clinically relevant PD-L1 expression. Heterogeneity of 89Zr-atezolizumab uptake will be evaluated by measuring standardized uptake value (SUV) on the 89Zr-atezolizumab PET/CT scan. - To study whether the amount of 89Zr-atezolizumab uptake, measured by the intensity of 89Zr-atezolizumab PET/CT imaging (SUV), can be used to differentiate between lymphoma activity and treatment-related inflammatory reaction (histiocytic/sarcoid-like reaction) in patients with an end-of-treatment 18F-FDG-positive PET/CT signal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters: - To correlate the pretreatment 89Zr-atezolizumab distribution to CAR T-cell peak expansion and persistence. - To correlate the pretreatment 89Zr-atezolizumab uptake to CAR T-cell therapy related grade 1-5 adverse events (cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS)). - To correlate tumor 89Zr-atezolizumab uptake with tumor and tumor infiltrating cell PD-L1 expression as assessed by immunohistochemistry on a fresh contemporaneous tumor biopsy. - To compare the 89Zr-atezolizumab distribution in irradiated versus non-irradiated lymphoma lesions in patients who require radiotherapy as a bridging strategy prior to CAR T-cell infusion. If possible, these results will be compared to tumor and immune cell PD-L1 expression as assessed by immunohistochemistry on a fresh contemporaneous tumor biopsy of an irradiated lymphoma lesion. - To determine the incidence of a treatment-related inflammatory signal on 18F-FDG-PET/CT scan (histiocytic/sarcoid-like reaction) after CAR T-cell therapy. | — |
Countries
Netherlands
Outcome results
None listed