Recruiting NCT06863233
A Study of CD8+ T Cell Imaging During Treatment in People With Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zirconium Zr 89 crefmirlimab berdoxam, PET/CT Scan.
- Who it may be relevant to
- Registry conditions: Lung Cancer, Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of Patients Immune Response After Treatment With Engineered Tumor Infiltrating Lymphocyte Therapy Incorporating CD8 PET Imaging
Overview
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
- Drug Zirconium Zr 89 crefmirlimab berdoxam
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 test PET/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).
Primary outcome measures
- Difference between Zirconium Zr 89 crefmirlimab berdoxam PET uptake at pre- vs post-TIL infusion and pre- vs post-ACZ redosing. [Time frame: Baseline to two weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 7 centers
- Memorial Sloan Kettering at Basking Ridge (Consent Only) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Consent Only) — Middletown
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only) — Commack
- Memorial Sloan Kettering Westchester (Consent only) — Harrison
- Memorial Sloan Kettering Cancer Center (All protocol activities) — New York
- Memorial Sloan Kettering Cancer Center @ Nassau (Consent only) — Uniondale
Identifiers
NCT: NCT06863233 · 24-369