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:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT06241456
Eligibility Criteria:
Inclusion Criteria:
* Histopathological or cytologically confirmed locally advanced or metastatic cancer that meets protocol-defined criteria
* Disease that is not amenable to curative therapy, with prior therapies defined by specific tumor types
* Contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to start of first study intervention
* Anticipated life expectancy of at least 3 months
Exclusion Criteria:
* Females who are pregnant or breastfeeding
* Evidence of inadequate organ function
* Clinically significant cardiovascular disease
* Known active central nervous system (CNS) involvement by malignancy
* Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment
* Active bacterial, fungal, or viral infections
* Prior receipt of chimeric antigen receptor (CAR) T-cell therapy, other cellular therapy, or a FATE investigational human induced pluripotent stem cell (iPSC) product
* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out based on imaging at screening
* Any history of Grade ≥3 immune-related AE or Grade ≥2 eye toxicity attributed to prior cancer immunotherapy, other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase
* Active or history of autoimmune disease or immune deficiency
* Receipt of an allograft organ transplant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06241456
Study Brief:
Protocol Section:
NCT06241456