FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, with or Without Monoclonal Antibodies in Advanced Solid Tumors

Launched by FATE THERAPEUTICS · Jan 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called FT825 (also known as ONO-8250), which is a type of therapy that uses specially modified cells to fight advanced solid tumors that are HER2-positive or other types of advanced cancers. The goal of the study is to find out how safe this treatment is, how well it works, and whether it can be improved by adding another type of medication called monoclonal antibodies after chemotherapy. The trial will start with a small group of patients to determine the right dose before expanding to include more participants.

To be eligible for this trial, patients should have a confirmed diagnosis of advanced cancer that can’t be treated with standard methods and have a life expectancy of at least three months. They should also be in fairly good health, as indicated by their ability to perform daily activities. However, certain individuals, such as pregnant or breastfeeding women, those with serious heart conditions, or people with active infections, cannot participate in the study. Participants can expect close monitoring during the trial, and their safety and health will be carefully tracked throughout the study.

Gender

ALL

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