Clinical trial NCT06863233: A Study of CD8+ T Cell Imaging During Treatment in People With Non-Small Cell Lung Cancer
Official title: Assessment of Patients Immune Response After Treatment With Engineered Tumor Infiltrating Lymphocyte Therapy Incorporating CD8 PET Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lung Cancer
Non Small Cell Lung Cancer
Metastatic Non Small Cell Lung Cancer
Keywords: Lung Cancer
Non Small Cell Lung Cancer
Metastatic Non Small Cell Lung Cancer
Memorial Sloan Kettering Cancer Center
24-369
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


Eligibility 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)

Primary outcomes:
measure: Difference between Zirconium Zr 89 crefmirlimab berdoxam PET uptake at pre- vs post-TIL infusion and pre- vs post-ACZ redosing.
timeFrame: Baseline to two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge (Consent Only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent Only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent Only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All protocol activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Adam Schoenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: