CD8 Minibody Repeatability Study | NCT05744128 | Trialant

CD8 Minibody Repeatability Study | NCT05744128 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Other	Eligible subjects will receive up to two zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 2.0 mCi ± 20% and 3.0 mg API) as an IV infusion or slow bolus injection. PET/CT imaging is performed 24hrs ± 3hrs post administration. The two scans are performed a minimum 2 weeks apart.	Biological: Zirconium 89Zr crefmirlimab berdoxam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zirconium 89Zr crefmirlimab berdoxam	Biological	Zirconium-89 labelled minibody for whole body PET imaging to visualize CD8+ cell distribution.	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SUVs in tumor	Absolute and relative difference in tumor SUVs	2-4 weeks
SUVs in reference tissues	Absolute and relative difference in reference tissue SUVs	2-4 weeks
ratio of tumor SUVs to reference tissue SUVs	Absolute and relative difference in SUV ratios	2-4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Safety of repeat doses of Zr-89 crefmirlimab berdoxam	Adverse events collected during the trial and as self-reported events.	Through study completion, an average of 8 weeks

Eligibility Module

Contacts/Locations Module

Condition Browse Module