A Clinical Trial of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma.

Официальное название

A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of B019 Injection in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma.

Обзор

The purpose of the study is to evaluate the safety、tolerability and preliminary efficacy of B019 in subjects with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Вмешательства

• Препарат B019
  B019： Intravenous infusion, 2.0×10\^6 cell/kg-8.0×10\^6 cell/kg

Первичные конечные точки

• Dose-limiting toxicity (DLT) [Срок оценки: Approximately 2 years]
• MTD（Maximum tolerated dose） [Срок оценки: Approximately 2 years]

Вторичные конечные точки (1)

• The overall response rate (ORR) [Срок оценки: Approximately 2 years]

Критерии участия

Критерии включения

• Subjects who can fully understand this trial and voluntarily sign the informed consent form (ICF) before any research-related procedures;
• Histologically confirmed B-cell non-Hodgkin's lymphoma (B-NHL) with specified pathological subtypes;
• Histologically confirmed CD19 and/or CD22 positivity;
• Expected survival time exceeding 12 weeks;
• ECOG performance status 0-1 (Ia) or 0-2 (Ib);
• At least one measurable lesion in two dimensions according to the Lugano 2014 criteria;
• Bone marrow, liver, kidney, and cardiac-pulmonary functions meeting the specified requirements; 8 Subjects who were evaluated by the researchers as tolerant to the collection of peripheral blood mononuclear cells (PBMC); 9 Subjects who were evaluated by the researchers as having no contraindications for lymphodepleting chemotherapy.

Критерии исключения

• Primary central nervous system (CNS) lymphoma; However, secondary CNS lymphoma without clinical symptoms can be enrolled after being determined by the researchers；
• Use of the prescribed drugs or treatments within the specified time before the collection of PBMC;
• Prior allogeneic hematopoietic stem cell transplantation;
• Systemic intravenous infusion treatment or uncontrollable bacterial, fungal or viral infection within 2 weeks before signing the ICF;
• A history of deep vein thrombosis or pulmonary embolism or anticoagulant therapy within 6 months before signing the ICF;
• A clinically significant history of severe heart disease within 6 months before signing the ICF;
• Terminal organ damage or autoimmune diseases requiring systemic immunosuppressive/systemic treatments within 2 years before signing the ICF; Or have graft-versus-host disease;
• Prescribed malignant tumors within 5 years before signing the ICF;
• Intestinal obstruction caused by tumor compression or vascular compression requiring emergency treatment; gastrointestinal involvement with a risk of bleeding assessed by the researchers;
• Clinically significant CNS diseases in the past or at the time of screening;
• A history of severe allergic reactions to the drugs or excipients that were definitely needed in this study. Or have a history of allergic reactions to tocilizumab;
• Any indwelling tubes or drainage tubes in the bodies, the use of dedicated central venous access catheters is permitted;
• Pregnant or breastfeeding women; or male or female subjects who are unwilling to use contraception from the time of signing the ICF until 1 year after receiving B019 injection cell infusion or until CAR is detectable in peripheral blood.;
• The subjects who have participated in other clinical studies within the past 1 month, or whose last medication use for the last clinical study is still within the 5 half-life periods of the current drug at the time of screening;
• Other circumstances that the researchers consider unsuitable for participating in this study.

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 · 7 центров

• Sun Yat-sen University Cancer Center — Гуанчжоу
• Zhujiang Hospital of Southern Medical University — Гуанчжоу
• Jiangxi Cancer Hospital — Nanchang
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Шанхай
• Shanghai General Hospital — Шанхай
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou
• Xijing Hospital — Сиань

Идентификаторы

NCT: NCT06970496 · B019-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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