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

  • End date
    May 23, 2025
  • participants needed
  • sponsor
    University Medical Center Groningen
Updated on 4 October 2022


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.

Condition Large B-cell Lymphoma
Treatment 89Zr-atezolizumab PET-imaging
Clinical Study IdentifierNCT05404048
SponsorUniversity Medical Center Groningen
Last Modified on4 October 2022


Yes No Not Sure

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
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