A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Официальное название

Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel

Обзор

The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.

Подробное описание

Cilta-cel (JNJ-68284528/LCAR-B38M chimeric antigen receptor T-cells \[CAR-T\]) is an autologous CAR-T therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. There will be no treatment administered during the study and the data obtained from this study will help to assess whether there will be long-term cilta-cel-related toxicities. The study will consist of 2 phases: within the first 5 years after receiving the last dose of cilta-cel and Year 6 to 15 years after last dose of cilta-cel. Safety evaluations will include a review of adverse events, laboratory test results, and physical examination findings (including neurological examination). The duration of the study is up to 15 years after last dose of cilta-cel and participants will be followed at least once per year.

Вмешательства

• Препарат Cilta-cel
  Participants who had received cilta-cel in previous studies will be followed up in this study. No additional study treatment will be administered to participants in this study.

Первичные конечные точки

• Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy [Срок оценки: Up to 15 years]
• Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder [Срок оценки: Up to 15 years]
• Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder [Срок оценки: Up to 15 years]
• Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia [Срок оценки: From year 1 up to year 5]
• Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia [Срок оценки: From year 6 up to year 15]
• Number of Participants with New Incidence of Grade >= 3 Infection [Срок оценки: From year 1 up to year 5]
• Number of Participants with Serious Infection [Срок оценки: From year 6 up to year 15]
• Number of Participants with Serious Adverse Events (SAEs) [Срок оценки: From year 1 up to year 5]
• Number of Participants with Related Serious Adverse Events Assessed by the Investigator [Срок оценки: From year 6 up to year 15]

Вторичные конечные точки (5)

• Number of Participants with Measurable Replication Competent Lentivirus (RCL) in Peripheral Blood [Срок оценки: Up to 15 years]
• Number of Participants with Chimeric Antigen Receptor (CAR) Transgene Level Greater Than (>) Lower Limit of Quantitation (LLOQ) in Peripheral Blood Cells [Срок оценки: Up to 15 years]
• Pattern of Lentiviral Vector Integration Sites [Срок оценки: Up to 15 years]
• Investigator's Response Assessment of Long Term Follow-up on Chimeric Antigen Receptor T-cell (CAR-T) Therapy Based on Local Lab Assessments [Срок оценки: Up to 15 years]
• Overall Survival (OS) [Срок оценки: Up to 15 years]

Критерии участия

Критерии включения

• Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
• Participants who have provided informed consent for 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

Другое

Центры проведения

США · 28 центров

• Mayo Clinic Cancer Center-Scottsdale — Phoenix
• City of Hope — Duarte
• University of California San Francisco — San Francisco
• Stanford University Medical Center — Stanford
• Moffitt Cancer Center — Tampa
• Emory University — Atlanta
• Northwestern University — Chicago
• University of Chicago — Chicago
• … и ещё 20 центров

Китай · 11 центров

• Peking University Third Hospital — Пекин
• West China Hospital Si Chuan University — Чэнду
• Fujian Medical University Union Hospital — Фучжоу
• Sun Yat-sen University Cancer Hospital — Гуанчжоу
• First Hospital, Zhejiang University Medical College — Ханчжоу
• Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School — Нанкин
• Jiangsu Province Hospital — Нанкин
• Shanghai Changzheng Hospital — Шанхай
• … и ещё 3 центра

Бельгия · 2 центра

• UZ Gent — Ghent
• UZ Leuven — Leuven

Франция · 2 центра

• CHRU de Lille Hopital Claude Huriez — Nord
• Hopital Saint Louis — Paris

Япония · 2 центра

• Nagoya City University Hospital — Nagoya
• Japanese Red Cross Medical Center — Shibuya City

Нидерланды · 2 центра

• VU Medisch Centrum — Amsterdam
• University Medical Center Groningen — Groningen

Испания · 2 центра

• Clinica Univ. de Navarra — Pamplona
• Hosp Clinico Univ de Salamanca — Salamanca

Израиль · 1 центр

• Tel Aviv Sourasky Medical Center — Tel Aviv

Идентификаторы

NCT: NCT05201781 · CR109123 · 68284528MMY4002 · 2020-005521-84 · 2023-505530-10-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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