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Идёт набор NCT06232096

A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.

Фаза I / Фаза II С лечением Relapsed or Refractory Multiple Myeloma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MBS314 Injection.
Кому может быть актуально
Состояния в реестре: Relapsed or Refractory Multiple Myeloma. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 Injection in Patients With Relapsed/Refractory Multiple Myeloma.

Обзор

This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel asymmetric trivalent tri-specific humanized antibody, MBS314, administered by intravenous (IV) infusion in participants with relapsed or refractory multiple myeloma. This entry-to-human study is divided in 2 parts: a dose escalation part (Phase Ⅰa) and an expansion part (Phase Ⅰb/Ⅱ).

Вмешательства

  • Препарат MBS314 Injection
    Phase Ia: The patients confirming to the eligibility criteria will be assigned to 1 of the 7 dose groups (0.03/0.09/0.3/0.9 mg \~ 0.3/1.5/9.0/60 mg, respectively) based on the sequence of inclusion. Each patient will receive MBS314 as per the schedule specified in the respective arms. Phase Ib/Ⅱ: Based on the results of Phase Ⅰa, 1 or 2 recommended doses will be selected for Phase Ⅰb. Recommended Phase II Dose (RP2D) will be selected for Phase Ⅱ.

Первичные конечные точки

  • Phase Ia:Percentage of Participants with Adverse Events (AEs) . [Срок оценки: From Baseline up to approximately 29 months]
  • Phase Ia:Incidence of Dose Limiting Toxicities (DLTs) [Срок оценки: From Baseline up to 4 weeks]
  • Phase Ia:Maximum Tolerated Dose (MTD) of MBS314 [Срок оценки: Up to approximately 11 months]
  • Phase Ia:Recommended Phase Ⅱ Dose (RP2D) of MBS314 [Срок оценки: Up to approximately 29 months]
  • Phase Ib/Ⅱ :Efficacy: Overall Response Rate (ORR) as Assessed by Independent Review Committee (IRC) [Срок оценки: Up to approximately 4 years]
Вторичные конечные точки (4)
  • Efficacy: Stringent Complete Response (sCR) Rate [Срок оценки: Up to approximately 4 year]
  • Efficacy: Complete Response (CR) or Better Rate [Срок оценки: Up to approximately 4 year]
  • Efficacy: Minimal Residual Disease (MRD) Negative Rate [Срок оценки: Up to approximately 4 years]
  • Efficacy: Very Good Partial Response (VGPR) or Better Rate [Срок оценки: Up to approximately 4 year]

Критерии участия

Критерии включения

  • Able and willing to provide written informed consent and to comply with the study protocol;
  • ≥18 years of age;
  • Documented diagnosis of multiple myeloma according to 2014 IMWG diagnostic criteria.
  • Phase Ⅰb/Ⅱ: At least one measurable disease: Serum monoclonal paraprotein (M-protein) ≥5 g/L or Urine M-protein ≥200 mg/24 hours or Serum immunoglobulin free-light chains (FLCs) ≥100 mg/L and abnormal kappa/lambda FLC ratio (<0.26 or >1.65)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Life expectancy ≥3 months.
  • Adequate hematologic, hepatic, and renal function.

Критерии исключения

  • Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
  • Participants with known active infection within 14 days prior to the first MBS314.
  • Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal hepatitis B virus DNA or hepatitis C virus RNA).
  • Previously received anti-myeloma treatment within the specified time frame prior to the first administration.
  • Live, attenuated vaccines within 28 days prior to the first infusion of MBS314, or expected to receive live, attenuated vaccines during the study period.
  • Major surgery within 28 days prior to the first infusion of MBS314, or expected to undergo major surgery during the study treatment.
  • Participants with a history of autoimmune diseases.
  • Known severe allergic reactions to other antibodies, or known allergies or hypersensitivity to any components of MBS314.

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
  • Institute of Hematology and Blood Diseases Hospital — Пекин

Идентификаторы

NCT: NCT06232096 · MBS314-CT101

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗