NCT05404048CompletedPhase 1/2
PD-L1 PET imaging during CAR T-cell therapy
Programmed death ligand 1 (PD-L1) PET imaging in patients with (Diffuse) Large B-cell Lymphoma who are treated with CD19-directed CAR T-cell therapy: a pilot study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Nov 2024
Brief summary (registry, in English)
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 the response to CD19-directed CAR T-cell therapy and thereby identify clinically relevant PD-L1 expression. 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 lymphoma activity and treatment-related inflammatory signal (histiocytic/sarcoid-like reaction) in patients with an end-of-treatment 18F-FDG-positive PET/CT signal.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 15 Nov 2024
- Start date
- 20 May 2026
- Lead sponsor
- Universitair Medisch Centrum Groningen
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT05404048
- EU CT number
- 2024-518422-32-01
- EudraCT number
- 2021-005192-39
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 20
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Signs or symptoms of active infection within 2 weeks prior to 89Zr-atezolizumab injection unless treated to resolution
Other illness
- History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Lab values
- 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
Who the study is looking for
- Histologically confirmed DLBCL and associated subtypes, defined by WHO 2016 classification: DLBCL not otherwise specified (NOS), High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and FL3B, Aggressive B-cell lymphoma, T-cell/histiocyte rich B-cell lymphoma, Primary mediastinal B-cell lymphoma, EBV+ DLBCL, transformed lymphoma (e.g. transformed follicular or marginal zone lymphoma)
- Eligible for CAR T-cell therapy according to criteria set by the Dutch National Tumor Board
- Measurable disease, as defined by Lugano criteria
- Signed informed consent
- Age ≥18 at the time of signing informed consent
- Ability to comply with the protocol
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.