BCMA CAR-T for Dynamic High-risk Multiple Myeloma

Официальное название

A Study of BCMA CAR-T for Dynamic High-risk Patients With Multiple Myeloma

Обзор

This is a single-arm, open-label study to evaluate the efficacy and safety of BCMA CAR-T in dynamic high-risk patients with multiple myeloma

Подробное описание

The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of BCMA CAR-T in dynamic high-risk patients with multiple myeloma. Patients received BCMA CAR-T cells infusion after standard FC lymphoma deletion therapy.

Вмешательства

• Биопрепарат anti-BCMA-CAR-T
  Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2.0-4.0 x 10\^6 anti-BCMA CAR+T cells/kg

Первичные конечные точки

• Safety and Tolerability [Срок оценки: Up to 2 year]
• MRD-negative rate [Срок оценки: within 3 months after BCMA CAR-T infusion]
• Persistent MRD-negative rate [Срок оценки: Up to 2 year]

Вторичные конечные точки (2)

• Progression free survival (PFS) [Срок оценки: Up to 2 year]
• Complete response rate (CRR) [Срок оценки: within 3 month after the CAR-T cell transfusion]

Критерии участия

Критерии включения

• Be informed and voluntarily sign the Informed Consent Form (ICF).
• Age between 18 and 75 years (inclusive).
• Have measurable disease meeting at least one of the following criteria: Serum M-protein ≥1 g/dL (>10 g/L) as detected by serum protein electrophoresis (SPEP), or quantifiable IgA or IgD levels for IgA or IgD-type myeloma; Urine M-protein ≥200 mg/24 hours; In cases where serum and urine M-protein do not meet the above thresholds, an abnormal free light chain (FLC) ratio (normal range: 0.26 to 1.65) and involved serum FLC ≥100 mg/L.
• Have received only one line of standard anti-myeloma therapy, including: Induction therapy with at least one proteasome inhibitor, one immunomodulatory agent, and corticosteroids; Sequential autologous hematopoietic stem cell transplantation or consolidation therapy; Maintenance therapy based on either a proteasome inhibitor or an immunomodulatory agent.
• Meet at least one of the following dynamic high-risk criteria: Early relapse: Disease progression or relapse within 18 months of starting first-line therapy, including progression or relapse within 12 months post-autologous hematopoietic stem cell transplantation; Primary refractory disease: Failure to achieve at least minimal response (MR) after four cycles of induction therapy; Relapse with new genetic abnormalities: Gain(1q), del(17p), or TP53 mutation.
• Confirmed expression of the BCMA target antigen on MM cells by flow cytometry or bone marrow immunohistochemistry.

Критерии исключения

• Primary plasma cell leukemia.
• Concurrent amyloidosis.
• Involvement of the central nervous system (CNS).
• Previous treatment with BCMA-targeted therapy or CAR-T cell therapy.
• Disease progression or relapse within 3 months of autologous hematopoietic stem cell transplantation.

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: NCT06880393 · IIT2024103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗