RecruitingPhase 1NCT06863233

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

Assessment of Patients Immune Response After Treatment With Engineered Tumor Infiltrating Lymphocyte Therapy Incorporating CD8 PET Imaging

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

5 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

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

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria2

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)

Interventions

DRUGZirconium 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.

DIAGNOSTIC_TESTPET/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).