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A Study of CD8+ T Cell Imaging During Treatment in People with Non-small Cell Lung Cancer
Trial Status: active
This phase I trial evaluates whether contrast enhanced positron emission tomography (PET)/computed tomography (CT) using zirconium Zr 89 crefmirlimab berdoxam is a safe and effective way to identify the immune response to treatment with membrane-bound IL-15-expressing tumor-infiltrating lymphocytes OBX-115 (OBX-115) in patients with non-small cell lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic). CD8+ T cells are a type of white blood cell commonly found around and attached to cancer cells, and these white blood cells play an active role in the immune system’s response to cancer. Contrast enhanced PET/CT is an imaging technique that utilizes PET and CT in a single machine, in which images are enhanced by the addition of contrast agents into the body. Zirconium Zr 89 crefmirlimab berdoxam is an imaging agent (radiotracer) made from two different parts. One part is an antibody (a type of protein) called crefmirlimab that attaches to CD8+ T cells. Antibodies are made by the immune system to stick to and attack specific targets on cells. The other part (Zr 89) gives off a small amount of radiation, which “lights up” the CD8+ T cells and makes them easy to see on the PET/CT scan. Tracking the location of CD8+ T cells through zirconium Zr 89 crefmirlimab berdoxam enhanced PET/CT may be a safe and effective way to identify the immune response to OBX-115 treatment in metastatic non-small cell lung cancer patients.
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 NCT06060613 (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)
Additional locations may be listed on ClinicalTrials.gov for NCT06863233.
I. Assess the distribution of the CD8+ cells during tumor infiltrating lymphocyte (TIL) therapy by measuring the largest difference in zirconium Zr 89 crefmirlimab berdoxam PET uptake at pre- versus (vs) post-TIL infusion and pre- vs post-acetazolamide (ACZ) redosing.
EXPLORATORY OBJECTIVES:
I. Describe frequency of successful completion of repeat zirconium Zr 89 crefmirlimab berdoxam imaging.
II. Explore the potential relationship between the largest difference in Zirconium Zr 89 crefmirlimab berdoxam PET/CT uptake and radiologic response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 to TIL therapy.
III. Explore the potential relationship between the largest difference in Zirconium Zr 89 crefmirlimab berdoxam PET/CT uptake and lesion level changes by RECIST 1.1 to TIL therapy.
IV. Explore the potential relationship between the largest difference in Zirconium Zr 89 crefmirlimab berdoxam PET/CT uptake and pseudo-progression by Immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST).
OUTLINE:
Patients receive zirconium Zr 89 crefmirlimab berdoxam intravenously (IV) over 5-10 minutes and undergo PET/CT 24 hours following infusion at baseline prior to lymphodepletion, 2 weeks post OBX-115 infusion, 1 week to 1 day prior to first ACZ redosing, and 1 week from completion of first ACZ redosing in the absence of unacceptable toxicity.
After completion of study intervention, patients are followed up at 4-6 weeks.
Trial PhasePhase I
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
