A phase 2 immunoPET imaging study with ZED88082A/CED88004S in patients with Large B-cell lymphoma before and after CD19-directed CAR T-cell therapy
- Conditions
- Large B-cell lymphomalymphoma10025320
- Registration Number
- NL-OMON51886
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 23
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).
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints:<br /><br>- To determine the whole-body biodistribution of the ZED88082A tracer in normal<br /><br>tissues and tumor lesions before and after CAR T-cell therapy. </p><br>
- Secondary Outcome Measures
Name Time Method