Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma

Официальное название

A Phase 1/2 Clinical Study Evaluating MDX2003 in Participants With Relapsed, Progressive, or Refractory B-Cell Malignancies

Обзор

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma

Вмешательства

• Препарат MDX2003
  MDX2003 intravenous infusion

Первичные конечные точки

• Part A only- Identify the Maximum Tolerated Dose (MTD) for expansion for further development of MDX2003 [Срок оценки: 28 days]
• All Study Parts: Adverse Events (AEs) [Срок оценки: Baseline until 90 days after the participant has the last dose of MDX2003]
• Part B only- Assess the preliminary anti-lymphoma activity of MDX2003 [Срок оценки: From date of enrollment until the end of treatment, up to approximately 6 months]

Вторичные конечные точки (7)

• All Study Parts: Measure of terminal half-life (t1/2) of MDX2003 [Срок оценки: 6 months]
• All Study Parts: Measure of area under the serum concentration-time curve (AUC) of MDX2003 [Срок оценки: 6 months]
• All Study Parts: Measure of time to maximum concentration (Tmax) of MDX2003 [Срок оценки: 6 months]
• All Study Parts: Measure of maximum serum concentration (Cmax) of MDX2003 [Срок оценки: 6 months]
• All Study Parts: Measure of volume of distribution (Vd) of MDX2003 [Срок оценки: 6 months]
• All Study Parts: Measure of system clearance of MDX2003 [Срок оценки: 6 months]
• All Study Parts: Evaluation of MDX2003 immunogenicity [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Participant must be ≥ 18 years of age.
• Participant has a confirmed diagnosis of large B-cell lymphoma (including DLBCL, high-grade B-cell lymphoma \[HGBCL\], primary mediastinal B-cell lymphoma \[PMBCL\], etc), FL, MCL, marginal zone lymphoma, transformation of indolent B-cell lymphoma, or lymphoplasmacytic lymphoma, including Waldenstrom macroglobulinemia.
• Participant has relapsed or progressed on at least 2 prior lines of therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• All participants must have measurable disease via computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)-CT.
• Documented CD19 or CD20 positivity of their B-cell neoplasm based on any representative pathology report from the past 3 months.
• Adequate hematologic, hepatic and renal function.
• All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Capable of giving signed informed consent.

Критерии исключения

• Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
• Unresolved toxicities from previous anticancer therapy.
• Primary central nervous system (CNS) lymphoma or known CNS involvement with lymphoma.
• Active medical condition requiring chronic systemic steroid use (>10 mg/day prednisone or equivalent of >140 mg over the last 14 days) or immunosuppressive therapy, within 6 months prior to the first dose of MDX2003.
• Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.
• Participant has a history of allogenic tissue or solid organ transplant, with the exception of corneal transplants.
• Known hypersensitivity to allopurinol or rasburicase.
• Participant has a seizure disorder requiring therapy at the time of screening (such as steroids or anti-epileptics).
• Participant is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 2 центра

• Epworth HealthCare — Richmond
• Linear Clinical Research — Nedlands

Идентификаторы

NCT: NCT07249905 · MDX-2003-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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