The CD19/CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-cell Malignancies

Официальное название

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19/CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-cell Malignancies

Обзор

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in the Treatment of Relapsed/Refractory B-cell Malignancies.

Подробное описание

This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in the patient ≥ 18 years of age with relapsed or refractory B-cell Malignancies. Subjects who meet the eligibility criteria will receive a single dose of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product. The study will include the following sequential phases: screening, bridging therapy (if needed), treatment, and follow-up.

Вмешательства

• Биопрепарат CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product
  Prior to infusion of theCD19/CD20 Dual-Target in vivo CAR-T Lentiviral product, subjects will receive bridging therapy if needed.

Первичные конечные точки

• Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events) [Срок оценки: Through study completion, an average of 2 years afterCD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)]
• Pharmacokinetics in peripheral blood [Срок оценки: Through study completion, an average of 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)]
• Pharmacokinetics in bone marrow [Срок оценки: Through study completion, an average of 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)]
• The recommended Phase II dose (RP2D) for this cell therapy [Срок оценки: 30 days after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion]

Вторичные конечные точки (6)

• Overall Response Rate (ORR) [Срок оценки: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)]
• Progression-free survival (PFS) [Срок оценки: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)]
• Overall Survival (OS) [Срок оценки: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)]
• Time to Response (TTR) [Срок оценки: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)]
• Duration of Response (DoR) [Срок оценки: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)]
• Immunogenicity assessment of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion [Срок оценки: Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)]

Критерии участия

Критерии включения

• Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.
• Age greater than or equal to 18.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• At least one evaluable tumor lesion.
• Relapsed and/or refractory NHL , and relapsed and/or refractory CLL with treatment indications
• Life expectancy≥ 3 months
• Clinical laboratory values meet screening visit criteria
• Adequate organ function;

Критерии исключения

Subject eligible for this study must not meet any of the following criteria:

• Prior antitumor therapy with insufficient washout period ;
• Prior treatment with lentiviral vector-based gene therapies;
• Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).
• Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).
• Lactating 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 · 6 центров

• The First Affiliated Hospital of USTC west district — Хэфэй
• Beijing Gobroad Boren Hospita — Пекин
• The Fourth Hospital of Hebei Medical University — Shijiazhuang
• The First Affiliated Hospital of ZHENGZHOU University — Чжэнчжоу
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Ухань
• The First Affiliated Hospital with Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT07002112 · LB2409-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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