A Clinical Study to Evaluate LVIVO-TaVec200 for the Treatment of Relapsed/Refractory Multiple Myeloma

Официальное название

A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the LVIVO-TaVec200 Product in the Treatment of Relapsed/Refractory Multiple Myeloma

Обзор

This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec200 in the treatment of relapsed/refractory multiple myeloma.

Подробное описание

This is a prospective, single-arm, open-label dose-escalation and dose-expansion study, designed to evaluate the safety, tolerability, anti-tumor efficacy profile, and pharmacokinetic characteristics of the LVIVO-TaVec200 in subjects with relapsed/refractory multiple myeloma who have failed at least 3 lines of prior standard therapies. The subject who meet the defined eligibility criteria will be enrolled with a core study period of approximately 2 years, including the screening, bridging therapy(if needed), treatment, and follow-up.

Вмешательства

• Биопрепарат LVIVO-TaVec200 product
  Prior to infusion of the LVIVO-TaVec200 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 after LVIVO-TaVec200 infusion (Day 1)]
• Pharmacokinetics in peripheral blood [Срок оценки: Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1)]
• Pharmacokinetics in bone marrow [Срок оценки: Through study completion, an average of 2 years after LVIVO-TaVec200 infusion (Day 1)]
• The recommended Phase II dose (RP2D) for this cell [Срок оценки: 30 days after LVIVO-TaVec200 infusion]

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 ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Has measurable lesions
• Relapsed and/or refractory multiple myeloma
• Life expectancy≥ 3 months
• Clinical laboratory values meet screening visit criteria
• Adequate organ function.

Критерии исключения

• Prior antitumor therapy with insufficient washout period ;
• Prior treatment targeting GPRC5D;
• 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).
• Any condition deemed by the investigator as rendering the subject unsuitable for participation 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 · 5 центров

• Henan Cancer Hospital — Чжэнчжоу
• The First Affiliated Hospital with Nanjing Medical University — Нанкин
• The Affiliated Hospital of XUZHOU Medical University — Xuzhou
• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Шанхай
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi’an

Идентификаторы

NCT: NCT07294625 · LB2503-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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