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

Официальное название

A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors

Обзор

This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.

Вмешательства

• Препарат FT825
  FT825 will be administered as an intravenous (IV) infusion at planned dose levels.
• Препарат Fludarabine
  Fludarabine will be administered as an IV infusion at planned dose levels.
• Препарат Cyclophosphamide
  Cyclophosphamide will be administered as an IV infusion at planned dose levels.
• Препарат Bendamustine
  Bendamustine will be administered as an IV infusion at planned dose levels.
• Препарат Docetaxel
  Docetaxel will be administered as an IV infusion at planned dose levels.
• Препарат Cisplatin
  Cisplatin will be administered as an IV infusion at planned dose levels.
• Препарат Cetuximab
  Cetuximab will be administered as an IV infusion at planned dose levels.

Первичные конечные точки

• Number of participants with dose limiting toxicities (DLTs) [Срок оценки: Up to approximately 29 days]
• Number of participants with treatment-emergent adverse events (TEAEs) [Срок оценки: Up to approximately 2 years]
• Severity of AEs [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (5)

• Investigator-Assessed Overall Response Rate (ORR) [Срок оценки: Up to approximately 2 years]
• Investigator-Assessed Duration of Response (DOR) [Срок оценки: Up to approximately 2 years]
• Progression-Free Survival (PFS) [Срок оценки: Up to approximately 2 years]
• Overall Survival (OS) [Срок оценки: Up to approximately 2 years]
• Plasma Concentration of FT825 [Срок оценки: At designated time points up to approximately 56 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 14 центров

• Banner MD Anderson Cancer Center — Gilbert
• University of California San Diego Moores Cancer Center — La Jolla
• Yale New Haven Hospital - Yale Cancer Center — New Haven
• University of Chicago Medical Center — Chicago
• Karmanos Cancer Institute — Detroit
• University of Minnesota Medical School — Minneapolis
• Washington University School of Medicine — St Louis
• Memorial Sloan Kettering Cancer Center — New York
• … и ещё 6 центров

Идентификаторы

NCT: NCT06241456 · FT825-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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