Multi-CAR-T Cells Targeting B Cell Lymphomas

Официальное название

Primary, Booster and Consolidation Multi-CAR-T Cell Therapy for the Treatment of Refractory B Cell Lymphomas

Обзор

This study aims to evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting B cell surface molecules including CD19 and alternative CARTs as booster and consolidation treatment for patients with highly resistant B cell lymphomas, including primary mediastinal B cell lymphoma (PMBCL) and BCL involving central nervous system (CNS-BCL). Clinical response and development of a simplified and 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

Chimeric antigen receptor (CAR) T cell therapy has proven effective in treating B cell malignancies. However, post CD19-CART relapses occur at high rate due to the CD19 antigen loss or the exhaustion of CART cells. Furthermore, the success of treating relapsed/refractory B cell lymphoma (BCL) such as primary mediastinal B-cell lymphoma (PMBCL) and CNS-involved BCL has been limited. To overcome tumor escape and prolong in vivo CART efficacy, we have developed a novel multiple CAR-T therapy regimen including booster and consolidation CART applications to to target highly-refractory cancer. Selected patients will be enrolled after target antigen confirmation including CD19, CD20, CD22, CD70, CD13, CD79b, GD2 and PSMA through immunostaining of their tumor specimens. The aim is to evaluate safety and long term efficacy of the multiple CART therapy strategy in the BCL patients.

Вмешательства

• Биопрепарат 4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2
  Patients who have relapsed and refractory B cell lymphoma (BCL) after conventional chemotherapy will be treated with multiple 4SCAR gene-engineered T cells

Первичные конечные точки

• Safety of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells infusion [Срок оценки: 24 weeks]

Вторичные конечные точки (1)

• Anti tumor activity of fourth generation anti-CD19 and anti-CD20/CD22/CD70/PSMA/CD13/CD79b/GD2 CAR-T cells infusion [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Age older than 6 months.
• Primary B cell lymphoma surface expression of CD19 and/or CD22/CD70/PSMA/ CD13/CD79b/GD2 molecules.
• 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

• Accompanied with other active diseases, and difficult to assess response after treatment.
• Bacterial, fungal, or viral infection, unable to control.
• Living with HIV.
• Active HBV and HCV infection.
• Pregnant and nursing mothers.6. under systemic steroid treatment within a week of the treatment.

7\. Prior failed CAR-T 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: NCT04429438 · GIMI-IRB-20006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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