Study of SYS6020 in BCMA-positive Multiple Myeloma

Официальное название

A Phase І Study of BCMA-targeted Chimeric Antigen Receptor T Cell (SYS6020) Injection in Relapsed or Refractory Multiple Myeloma

Обзор

This is a multi-center, phase I trial that studies the efficacy and recommended dose of BCMA CART cells in treating patients with BCMA-positive multiple myeloma (MM) that have not respond or relapsed after chemotherapy. B-cell maturation antigen (BCMA), a cell surface protein expressed on malignant plasma cell, has emerged as a very selective antigen to be targeted in novel immunotherapy for MM.

Вмешательства

• Биопрепарат BCMA Targeted CAR T-cells
  Each patient will receive BCMA Targeted CAR T-cells by intravenous infusion.

Первичные конечные точки

• Incidence of adverse events (AEs) [Срок оценки: Up to approximately 6 months]
• Dose limiting toxicities (DLTs) [Срок оценки: Up to 21 days]

Вторичные конечные точки (3)

• Overall response rate (ORR) [Срок оценки: Up to approximately 6 months]
• Percentage of subjects who achieved complete response or strict complete response (CR/sCR) [Срок оценки: Up to approximately 6 months]
• Percentage of subjects who achieved very good partial response (VGPR) and higher response rate [Срок оценки: Up to approximately 6 months]

Критерии участия

Критерии включения

• 1\. ≥ 18 years of age at the time of signing informed consent;
• 2\. Cytology or tissue biopsy meets diagnostic criteria for multiple myeloma (according to IMWG criteria);
• 3\. Bone marrow specimens confirmed positive BCMA expression in plasma cells and myeloma cells by immunohistochemistry or flow cytometry (>5%);
• 4\. Have measurable disease by International Myeloma Working Group (IMWG) criteria based on one or more of the following findings:

• Serum M-protein≥ 1 g/dL（≥10 g/L）
• Urine M-protein ≥ 200 mg/24 hour
• Involved serum free light chain (FLCs) level≥10 mg/dL with FLCs abnormal ratio (<0.26或>1.65)
• 5\. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
• 6\. Diagnosis of MM with relapsed or refractory disease and have had at least 1 prior lines of therapy.

Критерии исключения

• 1\. Patients with plasmacytic leukemia or Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organ enlargement, endocrinopathy, monoclonal protein and skin lesions) or amyloidosis at screening;
• 2\. Received any prior CAR-T therapy or BCMA targeted therapy;
• 3\. Patients who have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to monocyte collection or history of allogeneic stem cell transplantation;
• 4\. A history of immunodeficiency, including a positive HIV antibody test;
• 5\. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA above the lower limit of measurement or 1000 copies /mL (500 IU/mL), (whichever is lower), HCV antibody positive and HCV-RNA above the lower limit of measurement or 1000 copies /mL (whichever is lower);
• 6\. Patients who, in the judgment of the investigator, need but are unable to receive prophylactic treatment for Pneumocystis, Herpes Simplex Virus (HSV), or Herpes Zoster (VZV) prior to initiation of treatment, or Syphilis confirmatory positive;
• 7\. History of Bacillus Tuberculosis (TB) treatment within 2 years prior to first medication;
• 8\. Patients with a history of interstitial lung disease and/or severe lung function impairment;
• 9\. Have an active bacterial, fungal, or viral infection;
• 10.A history of severe cardiovascular disease.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06359509 · SYS6020-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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