Status:
ACTIVE_NOT_RECRUITING
PD-L1 PET-imaging During CAR T-cell Therapy
Lead Sponsor:
University Medical Center Groningen
Conditions:
Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 recept...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05404048
Start Date
May 18 2022
End Date
May 1 2026
Last Update
December 3 2025
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713GZ