CD8 Minibody Repeatability Study

Trial Title: CD8 Minibody Repeatability Study

NCT ID: NCT05744128

Condition: Melanoma
Renal Cell Carcinoma

Conditions: Official terms:
Carcinoma, Renal Cell

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Zirconium 89Zr crefmirlimab berdoxam
Description: Zirconium-89 labelled minibody for whole body PET imaging to visualize CD8+ cell distribution.
Arm group label: Single Arm

Other name: Zr-89 Df-crefmirlimab

Other name: Zr-89 Df-IAB22M2C

Summary: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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. Exclusion Criteria: - Patients with uncontrolled infection or other concurrent malignancies or conditions that may confound interpretation of the scans in the opinion of the investigator - Patients with urinary catheters or stoma bags - 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 - 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 - Participants on immunosuppressive medication e.g. cyclosporine, azathioprine, janus kinase inhibitors - 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Castle Hill Hospital

Address:
City: Hull
Zip: HU16 5JQ
Country: United Kingdom

Status: Recruiting

Start date: February 16, 2023

Completion date: December 15, 2025

Lead sponsor:
Agency: ImaginAb, Inc.
Agency class: Industry

Collaborator:
Agency: University of Hull
Agency class: Other

Source: ImaginAb, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05744128