A Trial to Evaluate the Safety and Efficacy of NCR300 in Preventing Recurrence of Acute Myeloid Leukemia（AML) After Transplantation

Официальное название

A Phase I or II Clinical Trial Evaluating the Safety and Efficacy of NCR300 Injection in Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation

Обзор

A Trial to Evaluate the Safety and Efficacy of iNK in the Treatment of Subjects for Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation.

Подробное описание

This is an open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR300 injection.

Вмешательства

• Биопрепарат NCR300 injection
  Subjects will receive at least 1 cycle of NCR300 injection.

Первичные конечные точки

• Dose-Limiting Toxicity(DLT) [Срок оценки: 4 weeks after initial infusion]
• Adverse Event(AE) or Serious Adverse Event(SAE) [Срок оценки: From the date of initial infusion to a year after initial infusion]

Вторичные конечные точки (4)

• Maximum plasma concentration(Cmax) [Срок оценки: 2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion.]
• Time after doing at which maximun plasma concentration is reached(Tmax) [Срок оценки: 2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion.]
• Cumulative Incidence of Relapse(CIR) [Срок оценки: 6 Months After Initial Infusion]
• Minimal Residual Disease(MRD) [Срок оценки: From the date of screening to a year after initial infusion]

Критерии участия

Критерии включения

1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF);

2.18-65years;

3.Clinical diagnosis of AML;

4.Accepted allogeneic blood stem cell transplantation within 60 to 28 days prior before initial infusion;

5.Complete donor chimerism and with high-risk recurrence factors prior to transplantation , or bone marrow examination shows positive MRD；

6.Have already recovered from the adverse reactions of previous treatment；

7.Having appropriate organ functions；

8.Eastern Cooperative Oncology Group(ECOG)<3;

9.Subjects who are able to comply with contraceptives from the study period to 6 months after the end of this study;

Критерии исключения

• Bone marrow examination shows hematological recurrence;
• Have malignant tumors within 5 years before screening;
• Subjects with acute promyelocytic leukemia(APL);
• Subjects with severe respiratory diseases;
• Subjects with clear history of neurological or psychiatric disorders in the past;
• Active central nervous system involvement；
• HIV(human immunodeficiency virus) antibody positive,treponema pallidum(TP) antibody positive.Have active hepatitis B or hepatitis C;
• Allergies to NCR300 or its excipients;
• Subjects with active cardiovascular and cerebrovascular diseases;
• Received organ transplantation or planned transplantation；
• Received other treatment drugs after transplantation；
• Graft-Versus-Host Disease (GVHD)>II grades;
• Subjects with active nervous system autoimmune or inflammatory diseases;
• Expected survival period within 3 months;
• Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;
• Having mental illness；
• Having uncontrollable active infections;
• Subjects whose state is not suitable for entering the study;
• Other situations determined by investigator that it is not suitable to enter the study.

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

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06441084 · NCR300-2002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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