An Open and Dose-escalation Early Clinical Study of CD19 and CD20 CAR-T Cell Therapy for Relapsed or Refractory Aggressive B-cell Lymphoma

Обзор

To observe the efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory or relapsed aggressive B-cell lymphoma

Подробное описание

In this study, anti-CD19 and anti-CD20 dual target CAR-T cell therapy will be explored for patients with relapsed/refractory aggressive B-cell lymphoma. In this study, the 3+3 dose climbing mode will be used to explore the safety and efficacy of dual-target CAR-T cells in r/r B-NHL therapy at different doses. The RP2D dose will be determined after the relevant data is summarized。

Вмешательства

• Биопрепарат CAR-T cell therapy
  autologous CD19+CD20 dual CAR-T cells, single injection

Первичные конечные точки

• the safety of CD19⁺CD20 CAR-T therapy [Срок оценки: 1 year after CAR-T cells therapy]

Критерии участия

Критерии включения

• The subject or his/her legal guardian is able to understand and voluntarily sign the informed consent form (ICF).
• Male or female subjects aged ≥18 years at the time of signing the ICF.
• An expected life expectancy of at least 12 weeks.
• An ECOG performance status of 0-2 at the time of signing the ICF.
• A diagnosis of relapsed or refractory aggressive B-cell lymphoma at the time of signing the ICF. Subjects must have previously received treatment with anthracycline-containing chemotherapy and rituximab (or other CD20-targeted agents), and must have experienced relapse or progression after at least two prior lines of therapy or autologous hematopoietic stem cell transplantation (ASCT).
• Presence of measurable positive lesions as defined by the Lugano criteria.
• Lymphoma lesions confirmed by biopsy to screening demonstrating expression of CD19 and/or CD20.
• Adequate major organ function.
• contraception.

Критерии исключения

• Lymphoma involving only the central nervous system (CNS) (except for secondary CNS lymphoma).
• History of CNS disorders.
• History of autoimmune disease requiring systemic immunosuppressive therapy within 4 weeks prior to signing the ICF.
• Presence of any uncontrolled active infection at the time of signing the ICF or within 2 weeks prior to leukapheresis, requiring antibiotic, antiviral, or antifungal treatment.
• Evidence of active infection, including: HBV DNA、Positive anti-HCV antibody with detectable HCV RNA、Positive HIV antibody、Positive cytomegalovirus (CMV) DNA、Positive Epstein-Barr virus (EBV) DNA、Positive both treponemal-specific and non-specific serologic tests for syphilis.
• Clinically significant cardiovascular disease.
• Known hypersensitivity to any component of the investigational products used in this study.
• Receipt of any disease-related investigational therapy or other systemic antitumor therapy prior to leukapheresis and within 5 half-lives of the drug.
• Requirement for systemic corticosteroids (at a dose equivalent to ≥20 mg/day of prednisone) or other immunosuppressive agents within 2 weeks prior to signing the ICF, within 2 weeks prior to leukapheresis, or during the study.
• Major surgery (excluding routine biopsy) within 4 weeks prior to signing the ICF, or planned major surgery during the study period.
• History of another primary malignancy within 5 years prior to signing the ICF, except for:

• Adequately treated and cured carcinoma in situ of the cervix;
• Localized basal cell carcinoma or squamous cell carcinoma of the skin.
• Receipt of a live attenuated vaccine within 4 weeks prior to signing the ICF, or planned vaccination with a live attenuated vaccine during the screening period.
• Any condition or complication that, in the investigator's opinion, may affect protocol compliance or make the subject unsuitable for participation in the study.
• Pregnant or breastfeeding 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

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07344818 · CD19+CD20 dual CAR-T

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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