Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients

Официальное название

Phase I/II Clinical Study to Evaluate the Safety and Efficacy of IM19 Chimeric Antigen Receptor T Cells(CAR-T) in the Treatment of Recurrent or Refractory (R/R) CD19 Positive Aggressive Non-Hodgkin's Lymphoma

Обзор

This is a phase I/II, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R/R Non-Hodgkins Lymphoma in China.

Подробное описание

This is a phase Ⅰ/Ⅱ. The phase I is a single-center study. The main objective is to evaluate the safety of IM19 CAR-T cell therapy for patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma. The phase Ⅱ is a multi-center study,The main goal is to evaluate the efficacy of IM19 CAR-T cells in the treatment of patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma.

Вмешательства

• Препарат IM19 CAR-T Cells
  IM19 CAR-T cells Drug: Fludarabine Two days before cell infusion, all patients will be treated with fludarabine for 3 days Drug: Cyclophosphamide Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days

Первичные конечные точки

• Objective Response Rate(ORR) at 90 days [Срок оценки: 90 days]

Критерии участия

Критерии включения

• Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types.
• CD20 positive patients undergo corresponding targeted therapy.
• Patients must have evaluable evidence of disease (according to Lugano 2014 standards).
• ≥ 18 years old.
• The expected survival period is more than 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up
• Participate voluntarily in this experiment and sign the informed consent.

Критерии исключения

• The investigators judged patients with gastrointestinal lymph nodes and/or central nervous system involvement who may be at risk for CAR-T treatment.
• Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease
• Subject has used chemotherapy or radiotherapy within three days before the blood collection period.
• Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids).
• Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs within 5 days before the blood collection
• Subject has used any gene therapy products before.
• Subject with a history of epilepsy or other central nervous system diseases.
• Active Hepatitis B Virus or Hepatitis C Virus infections
• The subject with other tumors in the past 5 years.
• Within 14 days before enrollment, there was active infection or uncontrollable infection requiring systemic 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

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT04440436 · SD45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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