A Study of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma

Официальное название

A Phase 1, Open-Label, Multi-center Study Evaluating the Safety and Tolerability of of JMT601 in Participants With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin Lymphoma

Обзор

This is a Phase 1, open-label, multi-center study to evaluate the safety of JMT601 in the treatment of relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma and to determine the recommended dose for Phase 2 studies (RP2D). Study consists of 2 parts. The first part is a dose-escalation part using a 3+3 design with up to 6 dose(0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 12 mg/kg and 20 mg/kg) escalation cohorts at increasing levels. The second part is a dose-expansion part at R2PD dose to assess preliminary efficacy of JMT601.

Вмешательства

• Биопрепарат JMT601
  intravenous infusion on day 1 once a week

Первичные конечные точки

• Dose-limiting toxicity(DLT) and maximum tolerated dose(MTD) [Срок оценки: DLTs and MTD: Up to 28 days after the first dose]
• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: TEAEs: Up to 90 days after last dose]

Вторичные конечные точки (12)

• Overall response rate (ORR) [Срок оценки: Up to 12 months]
• Duration of response (DOR) [Срок оценки: Up to 12 months]
• Progression free survival (PFS) [Срок оценки: Up to 12 months]
• Overall survival (OS) [Срок оценки: Up to 12 months]
• Aera under the curve from 0 to the last measurable concentration(AUClast) [Срок оценки: Up to 12 months]
• Aera under the curve from 0 to the infinite time(AUC0-∞) [Срок оценки: Up to 12 months]
• Time to maximum concentration(Tmax) [Срок оценки: Up to 12 months]
• Terminal phase half-life(T1/2) [Срок оценки: Up to 12 months]
• Clearance(CL) [Срок оценки: Up to 12 months]
• Volume(Vd) [Срок оценки: Up to 12 months]
• Maximum concentration( Cmax) [Срок оценки: Up to 12 months]
• Minimum concentration(Cmin) [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

• Participants diagnosed with CD20-positive B-cell non-Hodgkin lymphoma confirmed by histopathology and/or cell biology who have previously received 2 or more lines of therapy
• Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2
• Participants must have at least one evaluable or measurable lesion according to Lugano 2014 criteria.
• Expected survival of at least 3 months;
• Suitable organ and hematopoietic function:

• The absolute count of neutrophil (ANC) ≥1.0×109/L;
• Platelets ≥75×10\^9/L (if bone marrow invasion doesn't exist)/≥50.0×10\^9/L (if bone marrow invasion exists);
• Hemoglobin ≥90 g/L;
• Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min;
• Total bilirubin ≤1.5×ULN, alanine aminotransferase ≤2.5×ULN, aspartate aminotransferase ≤2.5×ULN; Subjects with liver lesion: TBIL≤3×ULN, ALT≤5×ULN, AST≤5×ULN;
• International Standardized ratio and activated partial thromboplastin time ≤1.5 × ULN;

Критерии исключения

• Confirmed central nervous system (CNS) lymphoma.
• Subjects who have received allogeneic hematopoietic stem cell transplantation (HSCT) or other organ transplantation
• Those who have previously received targeted CD47 or signal regulatory protein α (SIRRP α) therapy.
• Previous or current hemolytic anemia, Evans syndrome, arteritis;
• Subjects with previous or current other malignant tumors;
• Previous or current history of active autoimmune diseases;
• Subjects who had undergone major surgery within 4 weeks prior to initial dosing or expected to have major surgery during the study period;
• HIV infection, active syphilis, hepatitis B surface antigen (HBsAg) positive and HBV-DNA higher than the lower limit or 1000 copies /ml(500 IU/ml), HCV antibody positive and HCV-RNA higher than the lower limit or 1000 copies /ml

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

• Ruijin Hospital — Шанхай

Идентификаторы

NCT: NCT06725524 · JMT601-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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