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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05404048
Other study ID # 202100663
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 18, 2022
Est. completion date May 2025

Study information

Verified date November 2023
Source University Medical Center Groningen
Contact Janneke W de Boer, MD
Phone +31625573522
Email j.w.de.boer@umcg.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date May 2025
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands University Medical Center Groningen Groningen

Sponsors (1)

Lead Sponsor Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the expression of PD-L1 in normal tissue and lymphoma lesions before CAR T-cell therapy by 89Zr-atezolizumab PET/CT imaging. 2 year
Primary To correlate the pretreatment 89Zr-atezolizumab uptake to the objective response rate to CAR T-cell therapy. 2 year
Primary To evaluate the utility of the 89Zr-atezolizumab uptake to distinguish lymphoma activity from a treatment-related inflammatory reaction in patients with an end-of-treatment 18F-FDG-positive PET/CT signal. 2 year
Secondary To correlate the pretreatment 89Zr-atezolizumab distribution to CAR T-cell peak expansion and persistence. 2 year
Secondary 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)). 2 year
Secondary To correlate tumor 89Zr-atezolizumab uptake with tumor and immune cell PD-L1 expression as assessed by immunohistochemistry on a fresh contemporaneous tumor biopsy. 2 year
Secondary 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. 2 year
Secondary To determine the incidence of a treatment-related inflammatory signal on 18F-FDGPET/CT scan (histiocytic/sarcoid-like reaction) after CAR T-cell therapy. 2 year
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