Active, not recruitingNCT05404048Updated Dec 3, 2025

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

A Phase 2 interventional study of 89Zr-atezolizumab PET-imaging in Large B-cell Lymphoma, sponsored by University Medical Center Groningen. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by University Medical Center Groningen · Phase 2, Interventional, and Diagnostic

From the registry’s dates

Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.

Phase: Phase 2
Study type: Interventional
Enrollment: 20
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

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.

Conditions studied

Large B-cell Lymphoma

Keywords

PD-L1
CAR T-cell therapy
Imaging

In context

Lead sponsor

University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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

Phase: Phase 2
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 20 participants (estimated)

Study arms

Experimental
PD-L1 PET-imaging
The main intervention of this study is 89Zr-atezolizumab PET-scan combined with a low-dose CT-scan. The PET/CT scan will be performed before infusion of CAR T-cell therapy. In patients with an end-of-treatment F-FDG positive PET-signal a second 89Zr-atezolizumab PET/CT-scan will be performed.
Other: 89Zr-atezolizumab PET-imaging

Interventions

Other89Zr-atezolizumab PET-imaging
89Zr-atezolizumab tracer injection + PET/CT-scan

What researchers measure

Primary outcomes

To evaluate the expression of PD-L1 in normal tissue and lymphoma lesions before CAR T-cell therapy by 89Zr-atezolizumab PET/CT imaging.
Time frame: 2 year
To correlate the pretreatment 89Zr-atezolizumab uptake to the objective response rate to CAR T-cell therapy.
Time frame: 2 year
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.
Time frame: 2 year

Secondary outcomes

To correlate the pretreatment 89Zr-atezolizumab distribution to CAR T-cell peak expansion and persistence.
Time frame: 2 year
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)).
Time frame: 2 year
To correlate tumor 89Zr-atezolizumab uptake with tumor and immune cell PD-L1 expression as assessed by immunohistochemistry on a fresh contemporaneous tumor biopsy.
Time frame: 2 year
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.
Time frame: 2 year
To determine the incidence of a treatment-related inflammatory signal on 18F-FDGPET/CT scan (histiocytic/sarcoid-like reaction) after CAR T-cell therapy.
Time frame: 2 year

Study locations

1 site

University Medical Center Groningen
Groningen, 9713GZ, Netherlands

References and documents

Study documents

Protocol and statistical analysis plan · Jan 12, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05404048
Lead sponsor: University Medical Center Groningen
Responsible party: Sponsor
First posted: Jun 3, 2022
Start date: May 18, 2022
Primary completion: Dec 2025 (estimated)
Completion: May 2026 (estimated)
Last update: Dec 3, 2025

Study contacts

Tom van Meerten, MD,PhD

principal investigator · University Medical Center Groningen

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University Medical Center Groningen

Start the discussion