Идёт набор NCT05643742

A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies

Фаза I / Фаза II С лечением B-cell Lymphoma Non-Hodgkin Lymphoma B-cell Malignancy Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

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: CTX112.
Кому может быть актуально: Состояния в реестре: B-cell Lymphoma, Non-Hodgkin Lymphoma, B-cell Malignancy, Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL). Базовые параметры: от 18 лет · Все.
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, Австралия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Subjects With Relapsed or Refractory B Cell Malignancies

Обзор

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.

Подробное описание

This is an open-label, multi-center Phase 1/2 study of CTX112 in subjects with relapsed/refractory B cell malignancies. CTX112 is an is allogeneic CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).

Вмешательства

Биопрепарат CTX112
CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)

Первичные конечные точки

Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities [Срок оценки: From CTX112 infusion up to 28 days post-infusion]
Phase 2 (Cohort Expansion): Objective response rate [Срок оценки: From CTX112 infusion up to 60 months post-infusion]

Вторичные конечные точки (4)

Duration of Response [Срок оценки: From date of first objective response of complete response (CR)/partial response (PR) until date of disease progression or death due to any cause, assessed up to 60 months]
Duration of Clinical Benefit (DOCB) [Срок оценки: From date of first objective response of CR/PR until the relapse or death that followed the last response, assessed up to 60 months]
Progression Free Survival [Срок оценки: From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months]
Overall Survival [Срок оценки: From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months]

Критерии участия

Критерии включения

Age ≥18 years.
Refractory or relapsed B cell malignancy.
Eastern Cooperative Oncology Group performance status 0 or 1.
Adequate renal, liver, cardiac and pulmonary organ function.
Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX112 infusion.

Критерии исключения

Prior allogeneic hematopoietic stem cell transplant (HSCT).
Active or history of central nervous system (CNS) involvement by malignancy.
History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
Active HIV, hepatitis B virus or hepatitis C virus infection.
Previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence).
Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX112 infusion or with a nonbiological anticancer drug within 14 days prior to CTX112 infusion.
Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
Women who are pregnant or breastfeeding.

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

Здоровые добровольцы: Нет