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CD8 Minibody Repeatability Study (PRETZCEL)

Primary Purpose

Melanoma, Renal Cell Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Zirconium 89Zr crefmirlimab berdoxam
Sponsored by
ImaginAb, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Castle Hill HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

SUVs in tumor
Absolute and relative difference in tumor SUVs
SUVs in reference tissues
Absolute and relative difference in reference tissue SUVs
ratio of tumor SUVs to reference tissue SUVs
Absolute and relative difference in SUV ratios

Secondary Outcome Measures

Safety of repeat doses of Zr-89 crefmirlimab berdoxam
Adverse events collected during the trial and as self-reported events.

Full Information

First Posted
January 19, 2023
Last Updated
February 15, 2023
Sponsor
ImaginAb, Inc.
Collaborators
University of Hull
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1. Study Identification

Unique Protocol Identification Number
NCT05744128
Brief Title
CD8 Minibody Repeatability Study
Acronym
PRETZCEL
Official Title
Positron Emission Tomography Repeatability Evaluation of Tissue Zirconium 89Zr Crefmirlimab Berdoxam
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImaginAb, Inc.
Collaborators
University of Hull

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Renal Cell Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Zirconium 89Zr crefmirlimab berdoxam
Other Intervention Name(s)
Zr-89 Df-crefmirlimab, Zr-89 Df-IAB22M2C
Intervention Description
Zirconium-89 labelled minibody for whole body PET imaging to visualize CD8+ cell distribution.
Primary Outcome Measure Information:
Title
SUVs in tumor
Description
Absolute and relative difference in tumor SUVs
Time Frame
2-4 weeks
Title
SUVs in reference tissues
Description
Absolute and relative difference in reference tissue SUVs
Time Frame
2-4 weeks
Title
ratio of tumor SUVs to reference tissue SUVs
Description
Absolute and relative difference in SUV ratios
Time Frame
2-4 weeks
Secondary Outcome Measure Information:
Title
Safety of repeat doses of Zr-89 crefmirlimab berdoxam
Description
Adverse events collected during the trial and as self-reported events.
Time Frame
Through study completion, an average of 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bronwen Williams
Phone
+44 (0) 1482 462771
Email
Bronwen.Williams@hyms.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azeem Saleem, MB BS DMRT PhD FRCR
Organizational Affiliation
Castle Hill Hospital, Hull
Official's Role
Principal Investigator
Facility Information:
Facility Name
Castle Hill Hospital
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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CD8 Minibody Repeatability Study

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