Combination of Inaticabtagene Autoleucel With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission.

Официальное название

Clinical Study of Inaticabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission.

Обзор

Evaluate the safety and efficacy of Inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with MRD-positive initial complete remission in B-cell acute lymphoblastic leukemia.

Подробное описание

Evaluate the safety and efficacy of Inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with MRD-positive initial complete remission in B-cell acute lymphoblastic leukemia.

Вмешательства

• Биопрепарат Inaticabtagene autoleucel
  CNCT19 combined with autologous hematopoietic stem cell transplantation，Dose: （0.5 -2）x 10\^6/kg CNCT19 Cell Injection via intravenous infusion.

Первичные конечные точки

• Relapse-Free Survival [Срок оценки: From autologous hematopoietic stem cell transplantation to 2 years after transplantation]

Вторичные конечные точки (3)

• Overall survival rate [Срок оценки: From autologous hematopoietic stem cell transplantation to 2 years after transplantation]
• Cumulative recurrence rate [Срок оценки: From autologous hematopoietic stem cell transplantation to 2 years after transplantation]
• MRD negativity rate [Срок оценки: 28 days after the first CAR-T cell reinfusion]

Критерии участия

Критерии включения

• ECOG score of 0 to 1
• Newly diagnosed Ph-negative B-ALL within 6 months, achieving CR1 after standard induction chemotherapy, undergoing at least one consolidation therapy, and patients with bone marrow MRD ≥ 0.01% detected by routine flow cytometry.
• Or newly diagnosed Ph-positive B-ALL within 6 months, achieving CR1 after guideline-recommended induction chemotherapy (or use of TKI), undergoing at least one consolidation therapy, and patients with BCR-ABL1 \> 0% detected by routine q-PCR technology.
• No significant organ dysfunction
• Willing and meet the conditions for autologous hematopoietic stem cell transplantation

Критерии исключения

• Burkitt lymphoma/leukemia, heterozygous or double-expressor leukemia, or chronic myeloid leukemia in blast phase.
• Before screening or pre-treatment, bone marrow or peripheral blood with blasts ≥ 5%; or extramedullary leukemia.
• Individuals who have received CAR-T cell therapy before screening or pre-treatment; or patients who have undergone hematopoietic stem cell transplantation.
• Patients with associated genetic syndromes related to bone marrow failure, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndromes.

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

• National Institute of Hematology, Chinese Academy of Medical Sciences — Тяньцзинь

Идентификаторы

NCT: NCT06608732 · IIT2024037

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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