89ZR-CED88004S for Large B-cell lymphoma

Inclusion criteria

• {"criterion_text":"- Subjects with histologically confirmed LBCL and subtypes according to the WHO 2016 criteria\n- 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]\n- Who fulfill the eligibility criteria for anti-CD19 CAR T-cell therapy according the Immune Effector Cell Working Group Tumorboard\n- Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures\n- Measurable disease, as defined by Lugano criteria\n- Signed informed consent\n- Age ≥18 at the time of signing informed consent\n- Life expectancy ≥12 weeks\n- Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n- Ability to comply with the protocol"}

Exclusion criteria

• {"criterion_text":"- Signs or symptoms of active infection within 2 weeks prior to ZED88082A/CED88004S injection, unless treated to resolution\n- Prior CD19-directed CAR T-cell therapy or other bi-specific antibodies targeting CD19 receptor (e.g. blinatumomab)\n- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins\n- 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\n- Pregnant or lactating women\n- HIV-positive patients"}

Primary endpoints

• {"endpoint_text":"- To determine the whole-body biodistribution of the ZED88082A tracer in normal tissues and tumor lesions before and after CAR T-cell therapy. Heterogeneity of ZED88082A/CED88004S uptake evaluated by measuring standardized uptake value (SUV) on the ZED88082A/CED88004S-PET scan 2 days after ZED88082A/CED88004S injection.","definition_or_measurement_approach":"Whole-body biodistribution assessed by ZED88082A/CED88004S-PET imaging; heterogeneity evaluated by measuring standardized uptake value (SUV) on PET scan performed 2 days after tracer injection."}

Secondary endpoints

• {"endpoint_text":"- Assess safety and dosimetry ZED88082A/CED88004S uptake in the setting of CD19- directed CAR T-cell therapy","definition_or_measurement_approach":"Assessment of safety and dosimetry related to tracer uptake (dosimetry measurements and safety monitoring) in the context of CD19-directed CAR T-cell therapy."}
• {"endpoint_text":"- Correlative expression analysis between ZED88082A tracer SUV parameters in the tumor, CD8 expression in tumor biopsy, and response to CAR T-cell therapy","definition_or_measurement_approach":"Correlation analyses between tumor SUV parameters from PET, CD8 expression measured in tumor biopsy, and clinical response to CAR T-cell therapy."}
• {"endpoint_text":"- To perform correlative expression analysis between SUV parameters of ZED88082A tracer in the tumor, CD8 expression in tumor biopsy, and SUV parametersin the tumor and whole-body and CAR T-cell persistence, peak level and CAR T-cell phenotype as measured in the peripheral blood.","definition_or_measurement_approach":"Correlative analysis linking tumor and whole-body SUV parameters with CD8 expression in biopsy and CAR T-cell metrics (persistence, peak level, phenotype) measured in peripheral blood."}
• {"endpoint_text":"- Correlative expression analysis between ZED88082A tracer SUV parameters in the tumor, and grade 1-5 adverse events to CAR T-cell therapy, including cytokine release syndrome and neurotoxicity.","definition_or_measurement_approach":"Correlation of tumor SUV parameters with grade 1-5 adverse events to CAR T-cell therapy, including CRS and neurotoxicity (safety correlation analysis)."}
• {"endpoint_text":"- to correlate ZED88082A/CED88004S uptake in lymphoma to radiated to non-radiated areas infield and outfield of radiation therapy in patients receiving radiation therapy that require bridging to CAR T-cell infusion","definition_or_measurement_approach":"Comparison/correlation of tracer uptake in irradiated vs non-irradiated lymphoma lesions (in-field vs out-of-field) in patients who received radiotherapy as bridging to CAR T infusion."}

Netherlands

Earliest CTIS Part Ii Submission Date

14-01-2025

Latest Decision Or Authorization Date

30-01-2025

Processing Time Days

16

Number Of Sites

1

Number Of Participants

27

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands