A Multicenter Study of CAR-T Cells in Primary Ph+All

Официальное название

A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia

Обзор

A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia

Подробное описание

This study is a single-arm, open-label, multicenter clinical trial that plans to enroll approximately 50 adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia to undergo CD19 CAR-T cell therapy. The primary objective is to evaluate the efficacy of CD19 CAR-T therapy in adult patients with newly diagnosed Ph-positive acute lymphoblastic leukemia. The secondary objective is to assess the safety of CD19 CAR-T therapy in this patient population. The exploratory objectives include evaluating the in vivo expansion and persistence of CAR-T cells, as well as B-cell depletion.

Вмешательства

• Препарат CD19 CAR-T cells
  Each subject receive CD19/CD22 CAR T-cells by intravenous infusion

Первичные конечные точки

• Complete Molecular Response Rate after CD19 CAR-T Cell Therapy [Срок оценки: 28 days after infusion]

Вторичные конечные точки (4)

• Leukemia-Free Survival [Срок оценки: 2 years after infusion]
• Overall survival [Срок оценки: 2 years after infusion]
• Cumulative Incidence of Relapse [Срок оценки: 2 years after infusion]
• Complete Molecular Response Rate after CD22 CAR-T Cell Therapy [Срок оценки: 2 years after infusion]

Критерии участия

Критерии включения

• Age ≥ 18 years old, gender not restricted;
• Subjects diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) in accordance with the 2016 WHO Classification of Acute Leukemias;
• Abnormal B cells positive for CD19 and CD22 by immunophenotyping;
• Subjects positive for Philadelphia chromosome (Ph chromosome) and BCR/ABL1 fusion gene by chromosomal and corresponding genetic testing;
• Newly diagnosed B-ALL patients who have not received treatment with standard chemotherapy regimens;
• Serum total bilirubin ≤ 51 μmol/L, serum ALT and AST both ≤ 3 times the upper limit of the normal reference range, and serum creatinine ≤ 176.8 μmol/L;
• Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography;
• Subjects with no active pulmonary infection and oxygen saturation ≥ 92% without oxygen supplementation;
• Estimated survival time ≥ 3 months;
• ECOG performance status score 0-2;
• Females and males of childbearing potential must agree to use appropriate contraceptive measures before enrollment, during study participation, and within 6 months after infusion;
• Subjects voluntarily participate in this study and sign the informed consent form.

Критерии исключения

• Subjects meeting any of the following exclusion criteria are ineligible for enrollment in this study:

• Subjects with a history of epilepsy or other central nervous system diseases;
• Subjects with a prior history of QT interval prolongation or severe cardiac diseases;
• Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
• Subjects with untreated active infections;
• Subjects with serological evidence of chronic hepatitis B virus (HBV) infection who are unable or unwilling to receive standard prophylactic antiviral treatment, or have a detectable HBV viral DNA load; subjects with serological evidence of hepatitis C virus (HCV) infection who have not completed curative treatment or have a detectable HCV viral load;
• Human immunodeficiency virus (HIV) antibody positive;
• Syphilis antibody positive;
• Subjects who have previously received any gene therapy products;
• Subjects with other uncontrolled diseases who, in the investigator's judgment, are unsuitable for enrollment;
• Any other conditions that, in the investigator's judgment, may increase the risk to the subject or interfere with the study results.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The first affiliated hospital of medical college of zhejiang university — Ханчжоу

Идентификаторы

NCT: NCT07252336 · TXB2025020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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