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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-03

Study Completion Date

2028-03-03

Brief Summary

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The purpose of this study to learn whether PET/CT (positron emission tomography/computed tomography) scans using an imaging agent (radiotracer) called zirconium Zr 89 crefmirlimab berdoxam is a safe and effective way to identify CD8+ T cells

Detailed Description

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Conditions

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Lung Cancer Non Small Cell Lung Cancer Metastatic Non Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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)

Group Type EXPERIMENTAL

Zirconium Zr 89 crefmirlimab berdoxam

Intervention Type DRUG

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DRUG

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patient must be 18 years of age or older at the time of signing the informed consent.
* 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

* Pregnant or breastfeeding women
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Uniondale, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam Schoenfeld, MD

Role: CONTACT

646-608-4042

Alexander Shoushtari, MD

Role: CONTACT

646-888-4161

Facility Contacts

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Adam Schoenfeld, MD

Role: primary

646-608-4042

Adam Schoenfeld, MD

Role: primary

646-608-4042

Adam Schoenfeld, MD

Role: primary

646-608-4042

Adam Schoenfeld, MD

Role: primary

646-608-4042

Adam Schoenfeld, MD

Role: primary

646-608-4042

Adam Schoenfeld, MD

Role: primary

646-608-4042

Adam Schoenfeld, MD

Role: primary

646-608-4042

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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24-369

Identifier Type: -

Identifier Source: org_study_id

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