Идёт набор NCT06297226
Study of Arlocabtagene Autoleucel (BMS-986393) a GPRC5D-directed CAR T Cell Therapy in Adult Participants With 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: Arlocabtagene Autoleucel.
- Кому может быть актуально
- Состояния в реестре: 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
- США, Австралия, Канада, Япония
- 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 2, Open-Label, Multicenter Study of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL)
Обзор
The purpose of this study is to evaluate the effectiveness and safety of Arlocabtagene Autoleucel (BMS-986393) in participants with relapsed or refractory multiple myeloma.
Вмешательства
- Биопрепарат Arlocabtagene Autoleucel
Specified dose on specified days
Первичные конечные точки
- Cohort 1: Best overall response (BOR) of partial response (PR) or better [Срок оценки: Up to approximately 5 years]
Вторичные конечные точки (12)
- BOR of partial response (PR) or better [Срок оценки: Up to approximately 5 years]
- Best overall response (BOR) of complete response (CR) including stringent complete response (sCR) [Срок оценки: Up to approximately 5 years]
- Minimal residual disease (MRD) negative status [Срок оценки: Up to approximately 5 years]
- Time from BMS-986393 infusion to first documentation of response of partial response (PR) or better according to the International Myeloma Working Group (IMWG) Response Criteria assessed by an independent review committee (IRC) [Срок оценки: Up to approximately 5 years]
- Duration of response (DOR) assessed by an IRC [Срок оценки: Up to approximately 5 years]
- Progression-free survival (PFS) [Срок оценки: Up to approximately 5 years]
- Overall survival (OS) [Срок оценки: Up to approximately 5 years]
- Overall response rate (ORR) assessed by an Investigator [Срок оценки: Up to approximately 5 years]
- Complete response rate (CRR) assessed by an Investigator [Срок оценки: Up to approximately 5 years]
- Time to response (TTR) assessed by an Investigator [Срок оценки: Up to approximately 5 years]
- Duration of response (DOR) assessed by an Investigator [Срок оценки: Up to approximately 5 years]
- Progression-free survival (PFS) with BOR according to the IMWG Response Criteria assessed by Investigator [Срок оценки: Up to approximately 5 years]
Критерии участия
Критерии включения
- Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
- Received at least 4 classes of MM treatment \[including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, anti-BCMA therapy, and at least 3 prior lines of therapy (LOT).
- Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
- Participants must have measurable disease during screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Критерии исключения
- Active or history of central nervous system involvement with MM.
- Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded.
- Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis.
- Other protocol-defined Inclusion/Exclusion criteria apply.
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
США · 41 центр
- University of Alabama at Birmingham — Birmingham
- Banner MD Anderson Cancer Center — Gilbert
- University of Arkansas for Medical Sciences — Little Rock
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 214) — Los Angeles
- UCSF Helen Diller Medical Center at Parnassus Heights — San Francisco
- Colorado Blood Cancer Institute — Denver
- Mayo Clinic in Florida — Jacksonville
- Miami Cancer Institute at Baptist Health, Inc. — Miami
- … и ещё 33 центра
Япония · 5 центров
- Nagoya City University Hospital — Nagoya
- Hyogo Medical University Hospital — Nishinomiya
- Chiba University Hospital — Chiba
- University Hospital,Kyoto Prefectural University of Medicine — Kyoto
- Japanese Red Cross Medical Center — Tokyo
Австралия · 4 центра
- Royal Prince Alfred Hospital — Camperdown
- Royal Brisbane and Women's Hospital — Brisbane
- The Alfred Hospital — Melbourne
- St Vincent's Hospital — Melbourne
Канада · 2 центра
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary
- McGill University Health Centre — Montreal
Идентификаторы
NCT: NCT06297226 · CA088-1000