Imaging CD8+ T cells in patients with metastatic non-small cell lung cancer
Assessment of Patients Immune Response After Treatment With Engineered Tumor Infiltrating Lymphocyte Therapy Incorporating CD8 PET Imaging
This study is testing a special type of scan to see if it can safely find immune cells in patients with advanced lung cancer who are about to start a new treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | crefmirlimab |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06863233 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and effectiveness of using PET/CT scans with a radiotracer called zirconium Zr 89 crefmirlimab berdoxam to identify CD8+ T cells in patients diagnosed with metastatic non-small cell lung cancer. Participants must be enrolled in a specific engineered TIL cell therapy protocol but have not yet received treatment. The study will involve imaging procedures to assess the presence of these immune cells during the treatment process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of metastatic non-small cell lung cancer who are enrolled in a specific TIL cell therapy protocol.
Not a fit: Patients who are pregnant, breastfeeding, or have a history of splenectomy or significant splenic dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to monitor immune responses in lung cancer patients, potentially leading to improved treatment strategies.
How similar studies have performed: Other studies have explored similar imaging techniques in cancer treatment, indicating potential for success, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering at Basking Ridge (Consent Only) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Consent Only) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Consent only) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All protocol activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Adam Schoenfeld, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Adam Schoenfeld, MD
- Email: schoenfa@mskcc.org
- Phone: 646-608-4042
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.