PD-L1 PET imaging during CAR T-cell therapy
EU CTIS ID: 2024-518422-32-01
What this study is testing
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.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Signs or symptoms of active infection within 2 weeks prior to 89Zr-atezolizumab injection unless treated to resolution
- History of severe allergic, 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 from complications
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.