Lung Cancer, Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer
Conditions
Keywords
Lung Cancer, Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer, Memorial Sloan Kettering Cancer Center, 24-369
Brief 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
Interventions
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).
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between Zirconium Zr 89 crefmirlimab berdoxam PET uptake at pre- vs post-TIL infusion and pre- vs post-ACZ redosing. | Baseline to two weeks | 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. |
Countries
United States
Contacts
Primary ContactAdam Schoenfeld, MD
Backup ContactAlexander Shoushtari, MD
Outcome results
None listed