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Исследование по оценке нежелательных явлений и изменения активности заболевания подкожно (п/к) эпкоритамабом в качестве монотерапии или в сочетании со стандартной терапией у взрослых участников в Китае с В-клеточной неходжкинской лимфомой

2 ноября 2026 г. обновлено: Genmab

Фаза 1b/2, открытое исследование для оценки безопасности и предварительной эффективности эпкоритамаба в качестве монотерапии или в сочетании со стандартной терапией у китайских субъектов с В-клеточной неходжкинской лимфомой

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and toxicity of epcoritamab as a monotherapy and when combined with standard of care therapy [Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or Rituximab and lenalidomide (R2)] in adult participants in China with B-Cell Non-Hodgkin Lymphoma. Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of B-Cell Non-Hodgkin Lymphoma. Study doctors put the participants in groups called treatment arms. A monotherapy of epcoritamab and two different combination of epcoritamab with standard of care therapy (R-CHOP or R2) will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. Approximately 66 adult participants with B-Cell Non-Hodgkin Lymphoma will be enrolled in the study in approximately 21 sites in China.

In the monotherapy arm (Cohort 1), participants will receive subcutaneous epcoritamab in 28-day cycles. In the combination arms (Cohorts 2 and 3), participants in Cohort 2 will receive subcutaneous epcoritamab with standard of care therapy (R-CHOP) in 21-day cycles followed by 28-day cycles, participants in Cohort 3 will receive subcutaneous epcoritamab with standard of care therapy (R2) in 28-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

49

Фаза

  • Фаза 2
  • Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Китай
    • Beijing Municipality
      • Beijing, Beijing Municipality, Китай, 100071
        • The Fifth Medical Center of PLA General Hospital /ID# 230520
      • Beijing, Beijing Municipality, Китай, 100191
        • Peking University Third Hospital /ID# 228138
    • Fujian
      • Fuzhou, Fujian, Китай, 350001
        • Fujian Medical University Union Hospital /ID# 231890
    • Guangdong
      • Guangzhou, Guangdong, Китай, 510060
        • Sun Yat-Sen University Cancer Center /ID# 228033
      • Guangzhou, Guangdong, Китай, 510080
        • Guangdong Provincial People's Hospital /ID# 228028
      • Guangzhou, Guangdong, Китай, 510515
        • Nanfang Hospital of Southern Medical University /ID# 227916
    • Henan
      • Zhengzhou, Henan, Китай, 450008
        • Henan Cancer Hospital /ID# 228772
    • Hubei
      • Wuhan, Hubei, Китай, 430022
        • Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 231221
    • Hunan
      • Changsha, Hunan, Китай, 410006
        • Hunan Cancer Hospital /ID# 231859
    • Jiangsu
      • Suzhou, Jiangsu, Китай, 215006
        • The First Affiliated Hospital of Soochow University /ID# 228024
      • Xuzhou, Jiangsu, Китай, 221006
        • The Affiliated Hospital of Xuzhou Medical College /ID# 228774
    • Jiangxi
      • Nanchang, Jiangxi, Китай, 330006
        • The First Affiliated Hospital of Nanchang University /ID# 228771
      • Nanchang, Jiangxi, Китай, 330029
        • Jiangxi Provincial Cancer Hospital /ID# 231944
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Китай, 200065
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 227724
    • Sichuan
      • Chengdu, Sichuan, Китай, 610041
        • West China Hospital, Sichuan University /ID# 231434
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Китай, 300000
        • Tianjin Cancer Hospital /ID# 228135
    • Zhejiang
      • Hangzhou, Zhejiang, Китай, 310003
        • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 228154
      • Hangzhou, Zhejiang, Китай, 310022
        • Zhejiang Cancer hospital /ID# 228776

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

All Cohorts:

  • Life expectancy of >= 3 months on standard of care (SOC).

  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2.

  • Has one or more measurable disease sites:

    • Fluorodeoxyglucose-positron emission tomography (FDGPET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites.
    • >= 1 measurable nodal lesion (long axis > 1.5 cm and short axis > 1.0 cm) or >= 1.0 measurable extra-nodal lesion (long axis >= 1 cm) on CT scan or MRI. Note: A previously irradiated lesion must have demonstrated progression or residual disease in the lesion after radiotherapy to be considered measurable.

Cohort 1 Part 1 (Monotherapy Safety Run-in) Specific Criteria:

  • Must have histologically confirmed CD20+ Diffuse large B-cell lymphoma (DLBCL), or High-grade B-cell lymphoma (HGCBL) with MYC and BCL2 and/or BCL6 translocations and DLBCL feature, and follicular Lymphoma (FL) at most recent (previous or current) representative tumor biopsy based on the pathology report, according to the World Health Organization (WHO) 2016 (or later) classification.
  • Must have at least one prior treatment with an anti-CD20 monoclonal antibody (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
  • Must have relapsed or refractory disease. Note: Relapsed disease is defined as disease that has recurred >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed or failed to achieve an objective response during therapy or progressed within 6 months (<6 months) of completion of therapy.

Cohort 1 Part 2 (Monotherapy Expansion) Specific Criteria:

  • Must have histologically confirmed CD20+ DLBCL at most recent (previous or current) representative tumor biopsy based on the pathology report, inclusive of the following according to the World Health Organization (WHO) 2016 (or later) classification.

    • DLBCL, not otherwise specified (NOS) including de novo or histologically transformed from an earlier diagnosis of indolent lymphoma such as FL and nodal marginal zone lymphoma with a subsequent development of DLBCL relapse or.
    • "Double-hit" or "triple-hit" with DLBCL morphology (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Double- /triple-hit lymphomas without DLBCL morphology and those classified in WHO 2016 as HGBCL, NOS are not eligible.
    • FL Grade 3B.

  • Following safety run-in and up to the 12th participant (including the number of safety run-in participants) in Cohort 1, participants must have received at least 1 prior line of systemic therapies which must include an anti-CD20 monoclonal antibody containing combination therapy (e.g., rituximab). After safety run-in confirms tolerability of the full dose A of epcoritamab, participants must have received at least 2 prior lines of systemic therapies.

  • Must have either failed prior autologous HSCT, or be ineligible for autologous HSCT due to age, comorbidities, performance status, comorbidities, or insufficient response to prior treatment.

  • Must have relapsed or refractory disease. Note: Relapsed disease is defined as disease that has recurred >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed or failed to achieve an objective response during therapy or progressed within 6 months (< 6 months) of completion of therapy.

Cohort 2 Specific Criteria:

  • Must have newly diagnosed CD20+ DLBCL.

  • Must have one of the following histologically confirmed CD20+ DLBCL (de novo or histologically transformed from FL at most recent (previous or current) representative tumor biopsy based on the pathology report including one of the following diagnoses according to the WHO 2016 (or later) classification:

    • DLBCL, not otherwise specified (NOS);
    • "Double-hit" or "triple-hit" with DLBCL morphology (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations) Note: Double-/triple-hit lymphomas without DLBCL morphology and those classified in WHO 2016 as HGBCL, NOS are not eligible or;
    • FL Grade 3B

  • Eligible for standard R-CHOP for 6 cycles.

Cohort 3 Specific Criteria:

  • Must have histologically confirmed CD20+ Grade 1 - 3a Follicular Lymphoma stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma at most recent (previous or current) representative tumor biopsy and based on the pathology report, according to the WHO 2016 (or later) classification.
  • Must have R/R disease to at least one prior systemic anti-lymphoma treatment which must include an anti CD20 monoclonal antibody (e.g., rituximab). Participant who received only prior anti-CD20 monoclonal antibody monotherapy is not eligible. Note: Relapsed disease is defined as disease that previously responded to therapy but progressed >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response or progressed within 6 months (< 6 months) of completion of therapy.
  • Must be eligible for R2 per investigator determination.
  • Willing to take aspirin prophylaxis (participants with low or intermediate risk for thromboembolism) or prophylactic anticoagulant (if high risk for a thromboembolic event) (lenalidomide treated participants only).

Exclusion Criteria:

All Cohorts:

  • History of primary mediastinal lymphoma.
  • Autologous Stem Cell Transplantation within 100 days prior to enrollment.
  • Have received prior allogeneic hematopoietic stem cell transplantation at any time.
  • Have been treated with a bispecific antibody targeting CD3 and CD20.

Cohort 2 Specific Criteria:

- History of prior systemic anti-lymphoma therapy (including definitive radiotherapy) for Diffuse large B-cell lymphoma (DLBCL) other than corticosteroids.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Нерандомизированный
  • Интервенционная модель: Последовательное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Cohort 1 Part 1: Epcoritamab Monotherapy

Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Лекарство: Epcoritamab

Subcutaneous Injection (SC)

Другие имена:
  • АББВ-ГМАБ-3013
Экспериментальный: Cohort 1 Part 2: Epcoritamab Expansion

Participants will receive SC epcoritamab in 28 day cycles.
Лекарство: Epcoritamab

Subcutaneous Injection (SC)

Другие имена:
  • АББВ-ГМАБ-3013
Экспериментальный: Cohort 2: Epcoritamab + RCHOP

Participants will receive SC epcoritamab in combination with [intravenously (IV) infused rituximab, IV injected cyclophosphamide, IV infused doxorubicin, IV infused vincristine, and oral prednisone (R-CHOP)] in 21 day cycles followed by 28 day cycles.
Лекарство: Epcoritamab

Subcutaneous Injection (SC)

Другие имена:
  • АББВ-ГМАБ-3013
Лекарство: Cyclophosphamide

IV Injection

Лекарство: Rituximab

Intravenous (IV) Infusion

Лекарство: Doxorubicin

IV Infusion

Лекарство: Vincristine

IV Infusion

Лекарство: Prednisone

Oral; Tablet
Экспериментальный: Cohort 3: Epcoritamab + R2

Participants will receive SC epcoritamab in combination with [intravenously (IV) infused rituximab, and oral lenalidomide (R2)] in 28 day cycles.
Лекарство: Epcoritamab

Subcutaneous Injection (SC)

Другие имена:
  • АББВ-ГМАБ-3013
Лекарство: Rituximab

Intravenous (IV) Infusion

Лекарство: Lenalidomide

Oral; Capsule

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Best Overall Response (BOR)
Временное ограничение: Up to Approximately 5 Years

Best overall response (BOR) is defined as the percentage of participants in Cohort 1 Part 2 third line plus (3L) R/R DLBCL who achieved best overall response of complete response (CR) or partial response (PR) by Lugano 2014 criteria as assessed by independent review committee (IRC).
Up to Approximately 5 Years
Cohort 1 Part 1, Cohort 2, and Cohort 3: Number of Incidence of Dose-Limiting Toxicities (DLT)
Временное ограничение: Up to Approximately 5 Years

DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Up to Approximately 5 Years

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Percentage of Participants with Complete Remission (CR)
Временное ограничение: Up to Approximately 5 Years

CR is defined as the absence of lymphoma determined by Lugano 2014 criteria as assessed by IRC.
Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Number of Participants with Progression-free survival (PFS)
Временное ограничение: Up to Approximately 5 Years

PFS is defined as the time in months from the first dose of study drug to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Overall survival (OS)
Временное ограничение: Up to Approximately 5 Years

OS is defined for Cohort 1 epcoritamab monotherapy participants, as the time in months from first dose of epcoritamab to death from any cause.
Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Duration of response (DOR)
Временное ограничение: Up to Approximately 5 Years

DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
Up to Approximately 5 Years
Cohort 1 Part 2 [(3L+) R/R DLBCL]: Time-to-response (TTR)
Временное ограничение: Up to Approximately 5 Years

TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by IRC.
Up to Approximately 5 Years

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Genmab

Соавторы

AbbVie

Следователи

  • Директор по исследованиям: ABBVIE INC., AbbVie

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

10 марта 2022 г.

Первичное завершение (Оцененный)

1 октября 2027 г.

Завершение исследования (Оцененный)

1 октября 2027 г.

Даты регистрации исследования

Первый отправленный

18 января 2022 г.

Впервые представлено, что соответствует критериям контроля качества

20 января 2022 г.

Первый опубликованный (Действительный)

21 января 2022 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

4 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 ноября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • M21-103

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Сроки обмена IPD

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Критерии совместного доступа к IPD

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • КСО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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