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TerminatedPhase 2

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