MRD-Guided BCMA/CD3 Bispecific Antibody Treatment After Stem Cell Transplant for Newly Diagnosed Multiple Myeloma

Официальное название

A Prospective, Single-Arm Clinical Trial of MRD-Guided BCMA/CD3 Bispecific Antibody as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma

Обзор

This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of the BCMA/CD3 bispecific antibody (CM336) as maintenance therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma.

Вмешательства

• Препарат anti-BCMA/CD3 bispecific antibody
  Anti-BCMA/CD3 bispecific antibody (CM336) will be administered via a subcutaneous injection (SC).

Первичные конечные точки

• Minimal residual disease (MRD) negativity conversion rate [Срок оценки: Up to 24 months]

Вторичные конечные точки (4)

• Duration of MRD negativity [Срок оценки: Up to 24 months]
• Progression-Free Survival [Срок оценки: From enrollment to the date of disease progression or death, up to approximately 24 months.]
• Overall Survival (OS) [Срок оценки: From start of treatment until death from any caus, up to approximately 24 months.]
• Incidence and severity of adverse events (AEs) [Срок оценки: From the first dose through 30 days after the last dose, up to approximately 24 months.]

Критерии участия

Критерии включения

• Be able to understand and voluntarily signs the informed consent form (ICF).
• Age ≥ 18 years.
• Newly diagnosed multiple myeloma according to the International Myeloma Working Group (IMWG) criteria.
• MRD positivity (≥10-⁵) detected by EuroFlow.
• Previous therapy limited to first-line treatment only, including: (1) Induction therapy with a 3- or 4-drug regimen containing a proteasome inhibitor and/or an immunomodulatory drug and/or an anti-CD38 monoclonal antibody; (2) Single or tandem autologous stem cell transplantation (ASCT); (3) Up to 2-4 cycles of consolidation therapy post-ASCT are permitted, with the total number of induction plus consolidation cycles not exceeding 8.
• Completion of ASCT within ≤12 months from the start of induction therapy; and ≤6 months from the most recent ASCT at enrollment (≤7 months if consolidation therapy was administered).
• No prior maintenance therapy.
• Achieved at least a partial response (≥PR) according to the IMWG 2016 response criteria.
• Presence of measurable disease at diagnosis.

Критерии исключения

• Prior treatment with genetically modified adoptive cellular therapy.
• History of allogeneic stem cell transplantation or solid organ transplantation.
• Disease progression prior to enrollment (per IMWG 2016 response criteria), or presence of plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or light-chain amyloidosis not attributable to symptomatic multiple myeloma.
• Central nervous system involvement.

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 Chinese Academy of Medical Sciences — Тяньцзинь

Идентификаторы

NCT: NCT07409454 · IIT2025139

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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