Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1

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

NCT ID: NCT06863233Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2025-08-12

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

Arms & 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).

Outcome measures

Primary

  • Difference between Zirconium Zr 89 crefmirlimab berdoxam PET uptake at pre- vs post-TIL infusion and pre- vs post-ACZ redosing.

    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.

    Time frame: Baseline to two weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (7)

Memorial Sloan Kettering at Basking Ridge (Consent Only)

Basking Ridge, New Jersey, 07920

Recruiting
Adam Schoenfeld, MD · Contact

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, 07748

Recruiting
Adam Schoenfeld, MD · Contact

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, 07645

Recruiting
Adam Schoenfeld, MD · Contact

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

Commack, New York, 11725

Recruiting
Adam Schoenfeld, MD · Contact

Memorial Sloan Kettering Westchester (Consent only)

Harrison, New York, 10604

Recruiting
Adam Schoenfeld, MD · Contact

Memorial Sloan Kettering Cancer Center (All protocol activities)

New York, New York, 10065

Recruiting
Adam Schoenfeld, MD · Contact

Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)

Uniondale, New York, 11553

Recruiting
Adam Schoenfeld, MD · Contact
A Study of CD8+ T Cell Imaging During Treatment in People With Non-Small Cell Lung Cancer | Cancerify