A Study of CD8+ T Cell Imaging During Treatment in People With Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Zirconium Zr 89 crefmirlimab berdoxam
DrugZirconium 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.
PET/CT Scan
Diagnostic testEach patient will undergo up to four infusions of Zirconium Zr 89 crefmirlimab berdoxam followed by PET/CT 24 hours later (+/- 3 hours).
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Participants with Metastatic non-small cell lung cancer (NSCLC)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Difference between Zirconium Zr 89 crefmirlimab berdoxam PET uptake at pre- vs post-TIL infusion and pre- vs post-ACZ redosing.
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.
Time frame
Baseline to two weeksSponsors and contacts
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Source ClinicalTrials.gov