CD7 CAR-T Cell Therapy Targeting CD7-positive Relapsed/Refractory T Cell Lymphoma/Acute Leukemia

Официальное название

Clinical Study on the Efficacy and Safety of CD7 CAR-T Cell Therapy Targeting CD7-positive Relapsed/Refractory T Cell Lymphoma/Acute Leukemia

Обзор

CD7 molecules are thought to be associated with disease aggressiveness, drug resistance, and poor prognosis. Intensive chemotherapy, immunotherapy, hematopoietic stem cell transplantation (HSCT) and other treatment regimens have achieved remarkable results in the treatment of hematologic malignant diseases. Nevertheless, patients with hematologic malignancies may still tolerate acquired therapy during the above treatments, and molecular targeted immunotherapy provides a safe, efficient and specific treatment for such patients The scheme has attracted more and more researchers' attention. The use of CD7 molecules as a new target for molecularly targeted anti-tumor therapy may provide a new research direction for the treatment of CD7 relapsed/refractory hematologic malignancies.

Вмешательства

• Биопрепарат CD7 CART
  For intravenous infusion

Первичные конечные точки

• Evaluate the safety of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia [Срок оценки: up to one month after the CAR-T infusion]
• Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia [Срок оценки: one month and three month after the CAR-T infusion]
• Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia [Срок оценки: one month and three month after the CAR-T infusion]

Вторичные конечные точки (7)

• long-term efficacy [Срок оценки: up to one year after the CAR-T infusion]
• long-term efficacy [Срок оценки: up to one year after the CAR-T infusion]
• long-term efficacy [Срок оценки: up to one year after the CAR-T infusion]
• Cell pharmacokinetics Dynamic indicators [Срок оценки: Day7, Day10, Day14, Day28 after the CAR-T infusion]
• Cell pharmacokinetics Dynamic indicators [Срок оценки: Day7, Day10, Day14, Day28 after the CAR-T infusion]
• Cell pharmacokinetics Dynamic indicators [Срок оценки: up to one month after the CAR-T infusion]
• Cell pharmacokinetics Dynamic indicators [Срок оценки: up to one mpnth after the CAR-T infusion]

Критерии участия

Критерии включения

Subjects must meet all of the following criteria to be enrolled:

• Subjects diagnosed with relapsed/refractory lymphoma/leukemia:

• Relapsed/refractory T-cell malignant lymphoma: patients who have not remission and recurrence after at least 2 courses of standardized second-line or above treatment (including hematopoietic stem cell transplantation).
• Relapsed/refractory T-cell acute lymphocytic or myeloid leukemia meeting any of the following criteria:

i) Relapse: After achieving complete remission with a standard treatment regimen (including hematopoietic stem cell transplantation), blasts appear in peripheral blood or bone marrow (proportion>5%), or extramedullary diseases occur; ii) Refractory: No complete remission after at least two courses of standard induction therapy.

• Bone marrow flow cytometry detected tumor cells as CD7 and/or extramedullary lesions with a clear diagnosis of CD7 by pathological immunohistochemistry at the time of enrollment screening;
• If tumor cells are detected in peripheral blood during enrollment screening, flow cytometry must be used to detect that the immunophenotype of tumor cells on the surface of tumor cells is both negative for CD4 and CD8. If the immunophenotype on the surface of peripheral blood tumor cells is not CD4 and CD8 negative, the proportion of peripheral blood tumor cells must be ≤1%;
• Expected survival greater than 3 months from the date of signing the informed consent form;
• Subjects with a performance status of 0\~2 in the Eastern Cooperative Oncology Group (ECOG) score;
• 14 years old≤ age ≤ 75 years old, male or female;
• HGB at least ≥70g/L, blood transfusion is available;
• Liver and kidney function, heart and lung function meet the following requirements:

• creatinine ≤1.5×ULN;
• left ventricular ejection fraction ≥50%;
• Oxygen saturation >90%;
• Total bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN;
• Subject or guardian understands and signs the informed consent form.

Критерии исключения

• One of the following cardiac criteria occurs: atrial fibrillation; Myocardial infarction within the past 12 months; Prolonged QT syndrome or secondary QT Extension, to be determined by the researcher. Echocardiography with LVSF<30% or LVEF<50%; Clinically significant pericardial effusion; Heart function Incomplete NYHA III or IV (confirmed by echocardiography within 12 months after treatment);
• Active GVHD;
• Have a history of severe pulmonary dysfunction;
• Merge other advanced malignant tumors;
• Combination of severe or persistent infections that cannot be effectively controlled;
• Combination of severe autoimmune diseases or congenital immunodeficiency;
• Active hepatitis (hepatitis B virus deoxyribonucleic acid \[HBV-DNA ≥ 500 IU/ml and abnormal liver function\] or anti hepatitis C virus Positive for HCV Ab, HCV-RNA above the detection limit of the analytical method, and abnormal liver function;
• Human immunodeficiency virus (HIV) infection or syphilis infection;
• Have a history of severe allergies to biological products (including antibiotics);
• There are central nervous system disorders, such as uncontrolled epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, etc;
• Female patients who are pregnant or breastfeeding, or have a pregnancy plan within 12 months;
• The researcher believes that there may be situations that increase the risk to the subjects or interfere with the test 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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07008872 · XB-20240912-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗