CD8 Minibody Repeatability Study
Key facts
- Who runs it
- ImaginAb, Inc.
- Where
- United Kingdom1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 3 people enrolled
- Started
- 16 Feb 2023
- Ended
- 31 May 2024
- Type of study
- Interventional
- Treatments tested
- Zirconium 89Zr crefmirlimab berdoxam
- Record updated
- 3 December 2024
- Why it stopped
- Strategic decision
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Aged 18 years and above
- Patients with at least one imageable primary or metastatic lesion > 1 cm in the lymph nodes or soft tissue excluding bone on the most recent standard of care imaging done within the last 3 months
- Cohort 1: Patients with melanoma on single or multiple agent Immune Checkpoint Blockade (ICB) therapy with stable response status following initiation of therapy. Stable disease would be observed over at least 2 consecutive standard of care CT scans (usually done 8-12 weeks apart) after initiation of therapy
- Cohort 2: Patients with untreated renal cell carcinoma on active surveillance
- Women of child bearing potential must not be pregnant on study entry
- Participants must agree to follow contraceptive advice while on study and for 30 days after ending participation
Who cannot take part
- Patients with uncontrolled infection or other concurrent malignancies or conditions that may confound interpretation of the scans in the opinion of the investigator
- Patients who have received a vaccine recently can be included to the study but can only be scanned after a washout period of 2 weeks after the vaccine. If participants have a vaccine after the first PET-CT scan, the second PET-CT scan will be delayed for at least 2 weeks after the vaccine
- Participants on immunosuppressive medication e.g. cyclosporine, azathioprine, janus kinase inhibitors
- Patients on steroids except those on replacement dose of steroids for adrenal or pituitary insufficiency. Patients requiring steroids as therapy for an unresolved immune therapy related adverse event will be excluded
- Patients with urinary catheters or stoma bags
- Participant enrolled into another therapeutic intervention study
- Any other contraindication that makes the patient unsuitable to take part in the study in the opinion of the investigator
- Women who are pregnant or breast feeding
- Unable to provide informed consent
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Zr-89 crefmirlimab berdoxam is a Zirconium-89 labelled minibody developed by ImaginAb for full body PET imaging of CD8+ cell distribution (CD8 ImmunoPET). The primary objective of this study is to assess the test-retest repeatability of CD8 immunoPET imaging in oncology patients with stable disease.
The group in the trial
- Single ArmOther group
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.
Treatment: Zirconium 89Zr crefmirlimab berdoxam
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Positron Emission Tomography Repeatability Evaluation of Tissue Zirconium 89Zr Crefmirlimab Berdoxam
- Record updated
- 3 December 2024