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Идёт набор NCT06469281

A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers

Фаза I С лечением Epithelial Ovarian Cancer Primary Peritoneal Carcinoma Fallopian Tube Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 27T51, Cemiplimab, Bevacizumab.
Кому может быть актуально
Состояния в реестре: Epithelial Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 1a/1b Study of 27T51, an Anti-MUC16 CAR T Cell Drug Product Administered Alone or in Combination for Participants With Recurrent or Refractory Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Обзор

This study is researching an experimental CAR T cell therapy called 27T51, referred to as study drug. The study drug is a MUC16 targeting immune cell therapy focused on adult female participants with recurrent or difficult to treat epithelial ovarian, primary peritoneal or fallopian tube cancer. This study has two (2) major parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion. The aim of the dose escalation part will be to test the safety of 27T51 in a small number of participants to find the highest dose given to humans without unacceptable side effects. The aim of the dose expansion part will be to test 27T51 at the established dose level(s) from the dose escalation part and may include other medications given in combination with 27T51. Information collected from this study will help researchers understand more fully whether this immune cell therapy, also known as CAR T cell therapy, can be safely used to treat solid tumors such as ovarian cancer.

Подробное описание

Former Sponsor 2seventy bio

Вмешательства

  • Другое 27T51
    Intravenous (IV) infusion
  • Препарат Cemiplimab
    IV infusion
  • Препарат Bevacizumab
    IV Infusion

Первичные конечные точки

  • Incidence of treatment emergent adverse events (TEAEs) [Срок оценки: Up to 18 months]
  • Incidence of adverse events of special interest (AESIs) [Срок оценки: Up to 18 months]
  • Incidence of adverse events of dose limiting toxicities (DLTs) [Срок оценки: Up to 18 months]
  • Manufacturing feasibility of 27T51 [Срок оценки: Up to 3 years]
  • Overall response rate (ORR) as assessed by the investigator [Срок оценки: Up to 48 months]
Вторичные конечные точки (6)
  • ORR as assessed by the investigator [Срок оценки: Up to 48 months]
  • Duration of response (DoR) [Срок оценки: Up to 48 months]
  • Disease control rate (DCR) [Срок оценки: Up to 48 months]
  • Incidence of TEAEs [Срок оценки: Up to 48 months]
  • Incidence of AESIs [Срок оценки: Up to 48 months]
  • Incidence of DLTs [Срок оценки: Up to 48 months]

Критерии участия

Критерии включения

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer according to World of Health Organization (WHO) 2020 classification
  • Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer, as described in the protocol
  • Serum cancer antigen (CA) 125 ≥ 2 × upper limit of normal (ULN) as assessed at the local lab by a 510(k) cleared test at screening
  • Participants must have at least 1 measurable tumor lesion as defined by the response evaluation criteria in solid tumors (RECIST) 1.1.
  • Expected survival ≥ 3 months

Критерии исключения

  • Inadequate cardiovascular, renal and hepatic function, as described in the protocol
  • Absolute lymphocyte count (ALC) < 100 cells/μL at time of leukapheresis
  • History of Grade ≥ 2 hemorrhage within 30 days, or inadequate coagulation parameters, as described in the protocol
  • Known history or presence of clinically relevant central nervous system (CNS) pathology, as described in the protocol
  • Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune related adverse events (AEs)
  • Treatment with any cellular or gene therapy

Note: Other protocol-defined Inclusion/Exclusion criteria apply

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 5 центров
  • Massachusetts General Hospital — Boston
  • John Theurer Cancer Center Hackensack University Medical Center — Hackensack
  • Roswell Park Cancer Institute — Buffalo
  • UPMC Hillman Cancer Center — Pittsburgh
  • LDS Hospital — Salt Lake City

Идентификаторы

NCT: NCT06469281 · 27T51-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗