Actively Recruiting
Assessment of Patients Immune Response After Treatment With Engineered Tumor Infiltrating Lymphocyte Therapy Incorporating CD8 PET Imaging in Metastatic Non-Small Cell Lung Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-08-12
5
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of PET/CT scans with an imaging agent called zirconium Zr 89 crefmirlimab berdoxam to safely and effectively identify CD8+ T cells in people with metastatic non-small cell lung cancer (NSCLC). This Phase 1 study aims to assess immune response after treatment with engineered tumor infiltrating lymphocyte (TIL) therapy by comparing imaging uptake before and after TIL infusion and ACZ redosing. Participants diagnosed with metastatic NSCLC will receive up to four infusions of zirconium Zr 89 crefmirlimab berdoxam, an investigational anti-CD8 minibody radiolabeled with Zirconium-89. Each infusion is followed by a PET/CT scan about 24 hours later, with a timing window of plus or minus 3 hours. The study focuses on imaging changes from baseline to two weeks post-treatment. During the study, participants will undergo PET/CT scans and infusions as scheduled. Researchers will measure differences in PET uptake to monitor CD8+ T cell presence before and after treatment interventions. Safety and effectiveness of this imaging method will be tracked, with participation expected to last through the imaging and infusion period around the TIL therapy timeline.
CONDITIONS
Brief Title
A Study of CD8+ T Cell Imaging During Treatment in People With Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 must use effective double barrier contraceptive methods during the study and up to 30 days after the last investigational product administration.
- Patient or legally authorized representative provided signed informed consent.
- Patient or legally authorized representative provided written authorization for use and disclosure of protected health information.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Patients with a history of splenectomy or significant splenic dysfunction, such as splenomegaly or recurrent infections due to impaired immune function.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants receive up to four infusions of Zirconium Zr 89 crefmirlimab berdoxam followed by PET/CT scans 24 hours later (+/- 3 hours) to assess immune response during treatment.
Up to 4 infusion visits and 4 PET/CT scan visits
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Adam Schoenfeld, MD
A
Alexander Shoushtari, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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