Clinical Study of the Safety and Efficacy of ASCT Combined With CD7-CART in the Treatment of CD7+ TCL

Официальное название

A Clinical Study of the Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation in Combination With CD7-CART in the Treatment of CD7+ T-Cell Lymphoma

Обзор

To evaluate the safety and efficacy of autologous hematopoietic stem cell transfer (ASCT) combined with CD7-CART in the treatment of CD7+ TCL

Вмешательства

• Препарат ASCT+CD7-CART
  Intravenous infusion of CD7-CART 3 days after ASCT

Первичные конечные точки

• PFS rate at 1 year after ASCT conbined with CD7-CART [Срок оценки: at 1 year after ASCT conbined with CD7-CART]
• Incidence and Severity of Adverse Events after ASCT conbined with CD7-CART [Срок оценки: during 2 years after ASCT conbined with CD7-CART]

Вторичные конечные точки (9)

• Duration of Response (DOR) [Срок оценки: during 2 years after ASCT conbined with CD7-CART]
• Progression-free Survival (PFS) [Срок оценки: during 2 years after ASCT conbined with CD7-CART]
• MRD negetive rate [Срок оценки: at 3 or 6 month after ASCT conbined with CD7-CART]
• Time to Response (TTR) [Срок оценки: during 2 years after ASCT conbined with CD7-CART]
• Overall Survival (OS) [Срок оценки: during 2 years after ASCT conbined with CD7-CART]
• Cmax [Срок оценки: during 3 month after ASCT conbined with CD7-CART]
• Tmax [Срок оценки: during 3 month after ASCT conbined with CD7-CART]
• AUC(0-28d) [Срок оценки: during 28 days after ASCT conbined with CD7-CART]
• Tlast [Срок оценки: during 1 year after ASCT conbined with CD7-CART]

Критерии участия

Критерии включения

• With the subject's consent and having signed the informed consent form, willing and capable of adhering to the planned visits, study treatment, laboratory tests and other trial procedures;
• Age 18 to 65 years old, both male and female;
• Confirmed as T-cell non-Hodgkin's lymphoma type (including T-lymphoblastic lymphoma/leukemia) according to the World Health Organization's classification of hematopoietic and lymphoid tissue tumors (2022), and meeting one of the following three conditions: 1) Newly diagnosed with high-risk factors, such as Ann Arbor stage III/IV, large mass, bone marrow invasion, central nervous system (CNS) invasion, ETP phenotype, RAS activating mutation, TP53 deletion/mutation, etc., as assessed by the investigator; 2) Not achieving PR or better response after induction and consolidation therapy; 3) Patients not considered for allogeneic hematopoietic stem cell transplantation;
• Confirmed as tumor cells expressing CD7 by histopathology and/or cytology at the time of screening;
• With appropriate organ function: 1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN), if the investigator determines that the abnormal ALT and AST are due to the disease (such as liver infiltration or bile duct obstruction), the indicators can be relaxed to ≤ 5 times ULN; 2) Total serum bilirubin ≤ 2 times ULN, except for patients with Gilbert's syndrome; patients with Gilbert's syndrome and total bilirubin ≤ 3 times ULN and direct bilirubin ≤ 1.5 times ULN can be included; 3) Serum creatinine clearance rate ≥ 30 mL/min; 4) International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN; 5) Possessing the minimum level of lung reserve, defined as ≤ grade 1 dyspnea (CTCAE v5.0) and non-oxygen-dependent blood oxygen saturation ≥ 92%; 6) Left ventricular ejection fraction ≥ 50% by echocardiography; no clinically significant abnormal electrocardiogram findings; no clinically significant pericardial effusion and pleural effusion.
• Women of childbearing age have a negative blood/urine pregnancy test within 7 days before infusion. Any male and female patients with fertility must agree to use effective contraceptive methods throughout the study and for at least 2 years after the administration of study treatment.

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Критерии исключения

Subjects with one or more of the following are not eligible for this study:

• History of allergy to any of the components in the cell product;
• Severe cardiac disease, including but not limited to: Myocardial infarction, cardiac angioplasty, or stenting within 6 months prior to signing the ICF; unstable angina; severe cardiac arrhythmias; History of severe non-ischemic cardiomyopathy; Congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), NYHA score listed in Appendix II
• Have a history of autologous/allogeneic hematopoietic stem cell transplantation;
• stroke or seizure within 6 months prior to signing the ICF;
• Have autoimmune diseases, immunodeficiencies or other diseases that require immunosuppressant treatment;
• Within 3 years prior to signing the ICF, have malignancies other than T-cell hematologic tumors, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer, localized prostate cancer after radical resection, carcinoma in situ of the duct in situ after radical resection, carcinoma in situ of other sites one year after radical resection, and there has been no treatment during the screening period and there is no sign of recurrence;
• presence of uncontrolled active infection;
• Unstable systemic diseases judged by the investigator: including but not limited to severe hepatic, renal or metabolic diseases requiring drug treatment;
• Any of the following within 4 weeks prior to lymphocyte collection:

The DNA detection value of hepatitis B virus (HBV) in peripheral blood was higher than the lower limit of detection; Positive for hepatitis C virus (HCV) antibody and positive for peripheral HCV-RNA; positive for human immunodeficiency virus (HIV) antibodies; positive for syphilis antigen or antibody; Positive for CMV-DNA (10) application of prednisone (or equivalent amounts of other corticosteroids) in excess of 5mg/day within 1 week prior to lymphocyte collection; (11) Have used any CAR-T cell products or other genetically modified T-cell therapies; (12) Received CD7-targeted therapy; (13) History of live vaccination within 4 weeks prior to signing the ICF; (14) Have a history of alcoholism, drug abuse, or mental illness; (15) Other situations that the investigator considers unsuitable to participate in this study.

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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

• Blood Disease Hospital, Chinese Academy of Medical Sciences — Тяньцзинь

Идентификаторы

NCT: NCT07106723 · IIT2025051

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗