CD8 Minibody Repeatability Study (PRETZCEL)

November 28, 2024 updated by: ImaginAb, Inc.

Positron Emission Tomography Repeatability Evaluation of Tissue Zirconium 89Zr Crefmirlimab Berdoxam

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm

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
Zirconium-89 labelled minibody for whole body PET imaging to visualize CD8+ cell distribution.
Other Names:
  • Zr-89 Df-crefmirlimab
  • Zr-89 Df-IAB22M2C

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImaginAb, Inc.

Collaborators

University of Hull

Investigators

  • Principal Investigator: Azeem Saleem, MB BS DMRT PhD FRCR, Castle Hill Hospital, Hull

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 28, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAB-CD8-204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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