A Study of CD8+ T Cell Imaging During Treatment in People With Non-Small Cell Lung Cancer

Phase 1

Recruiting

• Conditions: Lung Cancer; Non Small Cell Lung Cancer; Metastatic Non Small Cell Lung Cancer
• Interventions: Drug: Zirconium Zr 89 crefmirlimab berdoxam; Diagnostic Test: PET/CT Scan

• Registration Number: NCT06863233
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Not available

Study Timeline

• Study Start: 2025-03-03
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-03
• Study First Posted: 2025-03-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2028-03-03
• Study Completion: 2028-03-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with Metastatic non-small cell lung cancer (NSCLC)	PET/CT Scan	Participants will have a diagnosis of metastatic non-small cell lung cancer (NSCLC)
Participants with Metastatic non-small cell lung cancer (NSCLC)	Zirconium Zr 89 crefmirlimab berdoxam	Participants will have a diagnosis of metastatic non-small cell lung cancer (NSCLC)

Primary Outcome Measures

Name	Time	Method
Difference between Zirconium Zr 89 crefmirlimab berdoxam PET uptake at pre- vs post-TIL infusion and pre- vs post-ACZ redosing.	Baseline to two weeks	Assess the distribution of the CD8+ cells during TIL therapy by measuring the largest difference in Zirconium Zr 89 crefmirlimab berdoxam PET uptake at pre- vs post-TIL infusion and pre- vs post-ACZ redosing.

Trial Locations

Locations (7)

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