Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT06863233
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06863233
Study Brief:
Protocol Section:
NCT06863233