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Clinical Trials in the Netherlands / NCT05404048
Active, not recruiting Phase 2

PD-L1 PET-imaging During CAR T-cell Therapy

NCT05404048 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 2
Started
2022-05-18
Last updated
2025-12-03

Condition(s) studied

Large B-cell Lymphoma

Investigational drug(s) / intervention(s)

89Zr-atezolizumab PET-imaging

89Zr-atezolizumab PET-imaging: 89Zr-atezolizumab tracer injection + PET/CT-scan

Study summary

This is a single-center, single-arm pilot trial designed to evaluate the expression of PD-L1 in patients with Large B-cell lymphoma (LBCL) and its role in non-responsiveness to chimeric antigen receptor (CAR) T-cell therapy in a non-invasive manner. Moreover, within this trial 89Zr-atezolizumab PET/CT imaging as a tool to distinguish lymphoma activity from a treatment-related inflammatory signal (histiocytic/sarcoid-like reaction) in patients with an end-of-treatment positive FDG PET/CT signal will be evaluated.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed LBCL and associated subtypes, defined by WHO 2016 classification * Tumor lesion(s) of which a histological biopsy can safely be obtained according to Standard clinical care procedures. * Measurable disease, as defined by Lugano criteria. * If has history of central nervous system (CNS) disease, then must have no signs or symptoms of CNS disease, no active disease on magnetic resonance imaging (MRI) and absence of large cell lymphoma in cerebral spinal fluid (CSF) on cytospin preparation and flow cytometry, regardless of the number of white blood cells. * If has history of cerebral vascular accident (CVA), the CVA event must be 12 months prior to apheresis and any neurological deficits must be stable. * Signed informed consent. * Age \>18 at the time of signing informed consent. * Life expectancy \>12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Ability to comply with the protocol. Exclusion Criteria: * Signs or symptoms of active infection within 2 weeks prior to 89Zr-atezolizumab injection, unless treated to resolution. * Prior CD19-directed CAR T-cell therapy or other bi-specific antibodies targeting CD19 receptor (e.g.blinatumomab). * History of severe allergy, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. * 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 for complications.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Medical Center Groningen Groningen Netherlands

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05404048 on ClinicalTrials.gov ↗ ← All trials in the Netherlands