CD8 PET imaging study before and after CAR T-cell therapy
- Conditions
- Patients with relapsed/refractory LBCL after 2 prior lines of therapy and qualify for CD19-directed CAR T-cell therapy. Eligibility for CAR T-cell therapy is based on the criteria posed by the Dutch Immune Effector Cell working group tumor board.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Registration Number
- EUCTR2020-004749-35-NL
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 22
1.Subjects with histologically confirmed LBCL and subtypes according to the WHO 2016 criteria
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.Signed informed consent.
5.Age =18 at the time of signing informed consent.
6.Life expectancy =12 weeks.
7.Eastern Cooperative Oncology Group (ECOG) performance status 0-1
8.Ability to comply with the protocol.
9.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 11
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
1.Signs or symptoms of infection within 2 weeks prior to ZED88082A/CED88004S injection.
2.Prior immune checkpoint inhibitor bi-specific antibody, including but not limited to anti-PD1 and anti- PD-L1 therapeutic antibodies.
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 ZED88082A/CED88004S, or that may affect the interpretation of the results or render the patient at high risk from complications.
5.Pregnant or lactating women.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method