A Study of CD8+ T Cell Imaging During Treatment in People With Non-Small Cell Lung Cancer
NCT ID: NCT06863233
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
5 participants
INTERVENTIONAL
2025-03-03
2028-03-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Participants with Metastatic non-small cell lung cancer (NSCLC)
Participants will have a diagnosis of metastatic non-small cell lung cancer (NSCLC)
Zirconium Zr 89 crefmirlimab berdoxam
Zirconium Zr 89 crefmirlimab berdoxam, the investigational agent proposed in this imaging study, is an anti-CD8 minibody (crefmirlimab), conjugated with deferoxamine (Df, berdoxam) and radiolabeled with Zirconium-89.
PET/CT Scan
Each patient will undergo up to four infusions of Zirconium Zr 89 crefmirlimab berdoxam followed by PET/CT 24 hours later (+/- 3 hours).
Interventions
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Zirconium Zr 89 crefmirlimab berdoxam
Zirconium Zr 89 crefmirlimab berdoxam, the investigational agent proposed in this imaging study, is an anti-CD8 minibody (crefmirlimab), conjugated with deferoxamine (Df, berdoxam) and radiolabeled with Zirconium-89.
PET/CT Scan
Each patient will undergo up to four infusions of Zirconium Zr 89 crefmirlimab berdoxam followed by PET/CT 24 hours later (+/- 3 hours).
Eligibility Criteria
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Inclusion Criteria
* Patient has a histologically confirmed diagnosis of metastatic non-small cell lung cancer
* Patient is enrolled in the engineered TIL cell therapy protocol OBX115-23-01, but has not received the treatment yet.
* Men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.
* Patient or legally authorized representative provided signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Patient or legally authorized representative provided written authorization for use and disclosure of protected health information.
Exclusion Criteria
* Patients with a history of splenectomy or significant splenic dysfunction (e.g., as evidenced by splenomegaly or a history of recurrent infections due to impaired immune function)
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Adam Schoenfeld, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, United States
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Adam Schoenfeld, MD
Role: primary
Adam Schoenfeld, MD
Role: primary
Adam Schoenfeld, MD
Role: primary
Adam Schoenfeld, MD
Role: primary
Adam Schoenfeld, MD
Role: primary
Adam Schoenfeld, MD
Role: primary
Adam Schoenfeld, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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24-369
Identifier Type: -
Identifier Source: org_study_id
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