Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Rondecabtagene autoleucel (ronde-cel), Fludarabine, Cyclophosphamide.
- Кому может быть актуально
- Состояния в реестре: Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Large B-cell Lymphoma. 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
- 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 1/2 Multi-Center Study Evaluating the Safety and Efficacy of Rondecabtagene Autoleucel, a CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cell Therapy in Participants With Aggressive B-Cell Non-Hodgkin Lymphoma
Обзор
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of rondecabtagene autoleucel (ronde-cel) also known as LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.
Подробное описание
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of ronde-cel, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.
Five cohorts of participants will be enrolled:
Cohort 1: (3rd or later line, 3L+) Participants who have received least two prior lines of treatment
Cohort 2: (CAR T-cell experienced, 3L+): Participants who have received at least two prior lines of treatment including one prior CAR T.
Cohort 3: (second line, 2L) Participants with refractory disease or relapse within one year of first-line therapy (second-line).
Cohort 4: (TCE-experienced, 3L+) Participants have received prior T-cell engager therapy and have received at least two prior lines of treatment including one TCE therapy and have not received prior CAR T.
Cohort 5: (high-risk 1st line) Participants receiving first-line treatment who remain with disease on positron emission tomography scanning (PET-positive) after 2 to 3 cycles of standard-of-care chemoimmunotherapy and have not received prior CAR T.
Up to approximately 150 participants (across all cohorts) will be enrolled in the dose finding Phase 1 part of the study.
The Phase 2 pivotal study (PiNACLE) will expand enrollment of Cohort 1 to approximately 120 participants to further evaluate the safety and efficacy of ronde-cel.
Ronde-cel treatment consists of a single administration of CAR transduced autologous T-cells administered intravenously after a conditioning chemotherapy regimen consisting of fludarabine and cyclophosphamide, administered over 3 days.
Individual participants will remain in the active post-treatment follow-up (PTFU) period for approximately 2 years. Participants will continue in long-term follow-up (LTFU) for 15 years from ronde-cel treatment.
Вмешательства
- Препарат Rondecabtagene autoleucel (ronde-cel)
CAR T-cell therapy - Препарат Fludarabine
Conditioning chemotherapy - Препарат Cyclophosphamide
Conditioning chemotherapy
Первичные конечные точки
- Phase 1: Evaluate the safety and tolerability of a single dose of ronde-cel administered as a single agent [Срок оценки: Baseline to Month 24]
- Phase 2: Estimate the efficacy of ronde-cel, as measured by overall response rate (ORR) [Срок оценки: Baseline to Month 24]
Вторичные конечные точки (10)
- Phase 1: Evaluate the efficacy of ronde-cel [Срок оценки: Baseline to Month 24]
- Phase 1: Evaluate the feasibility of treatment with ronde-cel [Срок оценки: Baseline to Month 24]
- Phase 1: Evaluate the pharmacokinetics of ronde-cel when administered as a single agent [Срок оценки: Baseline to Month 24]
- Phase 2: Estimate the efficacy of ronde-cel [Срок оценки: Baseline to Month 24]
- Phase 2: Estimate the efficacy of ronde-cel [Срок оценки: Baseline to Month 24]
- Phase 2: Estimate the efficacy of ronde-cel [Срок оценки: Baseline to Month 24]
- Phase 2: Estimate the efficacy of ronde-cel [Срок оценки: Baseline to Month 24]
- Phase 2: Estimate the efficacy of ronde-cel [Срок оценки: Baseline to Month 72]
- Phase 2: Evaluate the safety and tolerability of a single dose of ronde-cel administered as a single agent [Срок оценки: Baseline to Month 24]
- Phase 2: Evaluate the pharmacokinetics of ronde-cel when administered as a single agent [Срок оценки: Baseline to Month 24]
Критерии участия
Критерии включения
- Age 18 years or older
- Willing and able to provide written informed consent
- Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022)
- Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3
- Relapsed or refractory disease.
- At least 1 measurable lesion (per Lugano classification)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)
- Absolute neutrophil count (ANC) ≥ 1000/µL
- Platelet count ≥ 50,000/µL
- Absolute lymphocyte count (ALC) ≥ 200/µL
Other protocol-defined criteria apply.
Критерии исключения
- History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years
- Active central nervous system involvement
- History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
- Ongoing or impending oncologic emergency
- Recent systemic anti-cancer therapy or radiation
- Ongoing non-hematologic toxicities due to prior therapy
- History of allogeneic stem cell or solid organ transplantation
- Autologous stem cell transplantation within 6 weeks
- History of prior genetically modified cell therapy (Cohorts 1, 3, 4, 5) or no other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel) (Cohort 2).
- Primary immunodeficiency
- History of autoimmune disease resulting in end organ injury or requiring recent therapy
Other protocol-defined criteria apply.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 32 центра
- University of California-Irvine Medical Center — Irvine
- Cedars-Sinai Medical Center — Los Angeles
- University of California, Los Angeles (UCLA) Medical Center — Los Angeles
- Scripps Clinic — San Diego
- Colorado Blood Cancer Institute — Denver
- Medstar Georgetown University Hospital — Washington D.C.
- Augusta University Medical Center — Augusta
- Indiana Blood and Marrow Transplantation — Indianapolis
- … и ещё 24 центра
Австралия · 2 центра
- Royal Perth Hospital — Perth
- The Alfred Hospital — Melbourne
Идентификаторы
NCT: NCT05826535 · LYL314-101