PD-L1 PET imaging study during CAR T-cell therapy

Phase 1

• Conditions: Patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of therapy who fulfill the eligibility criteria for CD19-directed CAR T-cell therapy according the Immune Effector Cell Working Group Tumorboard.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2021-005192-39-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-18
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

In order to be eligible to participate in this study, subject must meet the following:
1.Histologically confirmed LBCL and associated subtypes, defined by WHO 2016 classification
2.Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
3.Measurable disease, as defined by Lugano criteria
4.If has history of 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.
5. If has history of cerebral vascular accident (CVA)
a.The CVA event must be >12 months prior to apheresis
b.Any neurological deficits must be stable
6.Signed informed consent.
7.Age =18 at the time of signing informed consent.
8.Life expectancy =12 weeks.
9.Eastern Cooperative Oncology Group (ECOG) performance status 0-1
10.Ability to comply with the protocol.
11.For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Signs or symptoms of active infection within 2 weeks prior to 89Zr-atezolizumab injection, unless treated to resolution.
2.Prior CD19-directed CAR T-cell therapy or other bi-specific antibodies targeting CD19 receptor (e.g. blinatumomab).
3.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
4.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.
5.Pregnant or lactating women.
6.HIV-positive patients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified