Clinical trial · Interventional
A Study of CD8+ T Cell Imaging During Treatment in People With Non-Small Cell Lung Cancer
Assessment of Patients Immune Response After Treatment With Engineered Tumor Infiltrating Lymphocyte Therapy Incorporating CD8 PET Imaging
NCT06863233CI-TRIAL-00123843completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/CT Scan | Diagnostic Test | — | UNRESOLVED |
| Zirconium Zr 89 crefmirlimab berdoxam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with Metastatic non-small cell lung cancer (NSCLC)
- description
- Participants will have a diagnosis of metastatic non-small cell lung cancer (NSCLC)
- interventionNames
- Drug: Zirconium Zr 89 crefmirlimab berdoxam
- Diagnostic Test: PET/CT Scan
Primary outcomes (1)
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.