CAR-T Immunotherapy Targeting CD19- ALL

Официальное название

CART Immunotherapy Targeting CD19 Negative Acute Lymphoblastic Leukemia

Обзор

This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Подробное описание

Anti-CD19 chimeric antigen receptor T cell therapy has demonstrated unprecedented treatment responses in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). However, many studies have reported that a subset of patients still relapse and about 30-50% of those relapses are characterized by the loss of CD19 surface antigen. Patients with CD19-negative relapse after CD19 CAR-T-cell therapy usually have a poor prognosis. The mechanisms underlying CD19-negative relapses are not fully understood and it is important to develop solutions to supplement post-CD19 immunotherapies.

Potential markers for recurrent leukemic blasts in an emerging CD19-negative blast population include many known B-cell lineage antigens. To prevent further target escape and improve the therapeutic effects, CAR gene-modified T cells targeting CD22, CD123, CD38, CD10, CD20 or TSLPR have been considered in post CD19 CAR-T immunotherapy. This study aims to evaluate safety and efficacy of administrating one or multiple non-CD19 targeting CAR-T cells to patients with CD19-negative B cell malignancies.

Вмешательства

• Биопрепарат 4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR
  4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR Patients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies

Первичные конечные точки

• Safety of infusion [Срок оценки: 24 weeks]

Вторичные конечные точки (1)

• Anti-tumor activity of CART [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Age older than 6 months.
• Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy.
• Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR.
• The KPS score over 80 points, and survival time is more than 1 month.
• Greater than Hgb 80 g/L.
• No contraindications to blood cell collection.

Критерии исключения

• Complications with other active diseases, and difficult to assess patient response.
• Bacteria, fungus, or virus infection, and unable to control.
• Living with HIV.
• Active HBV and HCV infection.
• Pregnant and nursing mothers.
• Under systemic steroid use within a week of the treatment.

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

Идентификаторы

NCT: NCT04016129 · GIMI-IRB-19003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗