Universal CAR-T Cells Targeting Multiple Myeloma

Официальное название

Universal CAR-T Cells for the Treatment of Multiple Myeloma

Обзор

The aim of this study is to assess the feasibility, safety and efficacy of universal CAR T cells targeting multiple myeloma. Another goal of the study is to learn more about the persistence and function of the universal CAR T cells in the body.

Подробное описание

Multiple myeloma (MM) is a malignancy of the plasma cells, which remains a clinical challenge despite advanced therapeutic interventions including novel molecular therapies and stem cell transplantation (SCT).

CAR-T therapy has proven to be a revolutionary treatment for hematological malignancies, but its manufacture is still limited by the high cost, and a long preparation time that is not conducive to timely treatment of patients. In addition, many MM patients suffer from long-term bone marrow suppression caused by tumor growth or prolonged and intense chemotherapies, resulting in exhaustion, aging and functional defects of autologous T cells, which substantially affect the quality of CAR-T cells and the clinical efficacy. The universal CAR-T cells could overcome many of the above problems.

By using universal type of CAR-T cells, the product can be supplied off-the-shelf without being customized from individual patients. In addition, the immediate availability means that patients under severe bone marrow suppression may get a chance to be treated with CAR-T cells to achieve disease remission. In addition, those patients who suffer from long-term immunosuppression due to tumor microenvironment or myelosuppressive chemotherapy would have the option of treatment with the universal CAR-T cells.

The purpose of this study is to assess the feasibility, safety and efficacy of several 4SCAR designs including BCMA, CD138, CD38 and CD19-specific universal CAR-T products targeting MM. Another goal is to learn more about the function of these universal CAR T cells and their persistency in the patients.

Вмешательства

• Биопрепарат MM-specific universal CAR T cells
  Infusion of MM-specific universal CAR T cells

Первичные конечные точки

• Percentage of patients with treatment related adverse effect [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Anti-tumor activity of the universal 4SCAR-T cells after infusion [Срок оценки: 3 months]
• Anti-tumor activity of fourth generation universal CAR-T cells in patients with relapsed or refractory MM [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Patients with confirmed multiple myeloma failed curative treatment options (including autologous or allogeneic SCT).
• Complete remission (CR) cannot be achieved after at least 2 prior therapy regimens.
• High risk MM in CR1 or CR2 and not eligible for SCT because of age or comorbid diseases.
• Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval < 1 year).
• Relapsed after prior autologous or allogenic SCT with residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.
• Residual disease after primary therapy and not eligible for ASCT
• Expected survival > 12 weeks• Creatinine < 2.5 mg/dl• ALT (alanine aminotransferase)/AST (aspartate aminotransferase) < 3x normal
• Bilirubin < 2.0 mg/dl
• Any relapse after prior SCT is eligible regardless of other prior therapy
• Adequate venous access for apheresis, and no other contraindications for leukapheresis
• Voluntary informed consent is signed

Критерии исключения

• Pregnant or lactating women
• Uncontrolled active infection
• Active hepatitis B or hepatitis C infection
• Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
• Previous related CAR-T cell therapy
• Any uncontrolled active medical disorder that would preclude participation
• HIV infection

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: NCT06006741 · GIMI-IRB-23003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗