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 lymphoma

Brief summary

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.

Detailed description

Assess safety and dosimetry ZED88082A/CED88004S uptake in the setting of CD19- directed CAR T-cell therapy, Correlative expression analysis between ZED88082A tracer SUV parameters in the tumor, CD8 expression in tumor biopsy, and response to CAR T-cell therapy, 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., 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., 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

Related papers

No related papers found yet.

Interventions

DRUG89Zr-CED88004S

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Assess safety and dosimetry ZED88082A/CED88004S uptake in the setting of CD19- directed CAR T-cell therapy, Correlative expression analysis between ZED88082A tracer SUV parameters in the tumor, CD8 expression in tumor biopsy, and response to CAR T-cell therapy, 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., 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., 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	—

Measure

Time frame

Assess safety and dosimetry ZED88082A/CED88004S uptake in the setting of CD19- directed CAR T-cell therapy, Correlative expression analysis between ZED88082A tracer SUV parameters in the tumor, CD8 expression in tumor biopsy, and response to CAR T-cell therapy, 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., 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., 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

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Countries

Netherlands

Outcome results

None listed