Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia

Официальное название

A Phase Ib, Clinical Trial of Hospital-manufactured CD19 Chimeric Antigen Receptor T Cells (SNUH-CD19-CAR-T) in Children and Adolescents With Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia

Обзор

Chimeric antigen receptor T cells (CAR-T cells) have been developed to treat relapsed and refractory hematological malignancies with promising outcome in patients with very poor prognosis. The purpose of this clinical study is to produce the CD19\[cluster of differentiation antigen 19\] CAR-T (SNUH-CD19-CAR-T) at the investigational site and to evaluate safety and efficacy of SNUH-CD19-CAR-T in children and adolescent with relapsed/refractory B-cell acute lymphoblastic leukemia.

Вмешательства

• Биопрепарат SNUH-CD19-CAR-T
  SNUH-CD19-CAR-T is an autologous CAR-T from T cells collected from each patient. Administer a single dose of SNUH-CD19-CAR-T to patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukemia, and evaluate safety and efficacy of SNUH-CD19-CAR-T for 12 months after the infusion.

Первичные конечные точки

• Incidence of adverse events and its severity [Срок оценки: 12 months post SNUH-CD19-CAR-T infusion]

Вторичные конечные точки (2)

• Patients with CR[complete remission] after Hospital-manufactured CAR-T infusion [Срок оценки: 1 month post SNUH-CD19-CAR-T infusion]
• Overall survival and event-free survival [Срок оценки: 12 months post SNUH-CD19-CAR-T infusion]

Критерии участия

Критерии включения

• 1\. Relapsed or refractory CD19 Positive Acute Lymphoblastic Leukemia. All subjects must be younger than 26 years old at the time of obtaining informed consent

a. 2nd or greater BM\[bone marrow\] relapse OR b. Any BM relapse after allogeneic SCT\[stem cell transplant\] and must be ≥ 6 months from SCT at the time of SNUH\_CD19\_CAR-T infusion OR c .Refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia OR d. Ineligible for allogeneic SCT because of:

• Severe comorbid disease
• Other contraindications to allogeneic SCT conditioning regimen
• Lack of suitable donor

2\. Documentation of CD19 tumor expression in bone marrow or peripheral blood by flow cytometry.

3\. Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) performance status ≥ 50 at screening

Критерии исключения

• Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) based on assessment done by treating physicians.
• Known human immunodeficiency virus (HIV) infection.
• Presence of clinically active uncontrolled infection based on assessment done by treating physicians. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
• Pregnant or nursing (lactating) women.

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

South Korea · 1 центр

• Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT05210907 · SNUH_CART_CD19ALL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗