Multi-CAR T Cell Therapy for Acute Myeloid Leukemia

Официальное название

Multi-center Phase I/II Clinical Trial of Multi-CAR T Cell Therapy for Acute Myeloid Leukemia

Обзор

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multi-CAR T cell therapy targeting different AML surface antigens in patients with relapsed or refractory acute myeloid leukemia (AML). Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.

Подробное описание

Acute myeloid leukemia (AML) is a malignant disease characterized by the rapid growth of myeloblasts that build up in the bone marrow and interfere with the production of normal blood cells.

In this study, the patients' own T cells will be genetically modified with lentiviral vectors expressing chimeric antigen receptors. The multi-CAR T cells recognize specific molecules such as CD33, CD38, CD123, CD56, MucI, and CLL1, which are often found expressed on the surface of AML cells. The engineered CAR T cells will be infused into patients.

The purpose of this clinical study is to assess the feasibility, safety and efficacy of the multi-CAR T cell therapy against AML. Another goal of the study is to learn more about the function of the multi-CAR T cells and their persistency in the patients.

Вмешательства

• Биопрепарат Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
  Infusion of Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells

Первичные конечные точки

• percentage of patients with treatment related adverse effect [Срок оценки: a year]

Вторичные конечные точки (1)

• Anti tumor activity of fourth generation CAR-T cells in patients with relapsed or refractory AML [Срок оценки: a year]

Критерии участия

Критерии включения

• Age older than 2 years.
• CD33, CD38, CD56, CD123, MucI, and CLL1 expression can be identified in the malignant cells by immuno-histochemical staining or flow cytometry.
• Karnofsky performance status (KPS) score is higher than 80 and life expectancy > 2 months.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL.
• Hgb≥80g/L.
• No cell separation contraindications.
• Abilities to understand and the willingness to provide written informed consent.

Критерии исключения

• Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.
• Active bacterial, fungal or viral infection not controlled by adequate treatment.
• Known HIV or hepatitis B virus (HBV) infection.
• Pregnant or nursing women may not participate.
• History of glucocorticoid for systemic therapy within the week prior to entering the test.
• Previously treatment with any gene therapy products.
• Patients, in the opinion of investigators, may not be eligible or not able to comply with 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

Лечение

Центры проведения

Китай · 1 центр

• Shenzhen Geno-immune Medical Institute — Шэньчжэнь

Публикации

• Pei K, Xu H, Wang P, Gan W, Hu Z, Su X, Zhang H, He Y. Anti-CLL1-based CAR T-cells with 4-1-BB or CD28/CD27 stimulatory domains in treating childhood refractory/relapsed acute myeloid leukemia. Cancer Med. 2023 Apr;12(8):9655-9661. doi: 10.1002/cam4.5916. Epub 2023 Apr 9. PMID 37031462

Идентификаторы

NCT: NCT03222674 · GIMI-IRB-17015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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