A Clinical Study of BT02 in Patients With Relapsed or Refractory Hematologic Malignancies

Официальное название

A Multicenter, Open-label, Single-arm Phase Ib/IIa Clinical Study to Evaluate the Safety and Efficacy of BT02 in Patients With Relapsed or Refractory Hematologic Malignancies

Обзор

The goal of this clinical trial is to learn about the safety, tolerability and preliminary effectiveness of a treatment for patients with relapsed or refractory hematologic malignancies, regardless of gender, aged between 18(inclusive) and 70 years . Participants will receive the investigational product intravenously every two or three weeks. The treatment will continue for a maximum of two years for those who do not show signs of disease progression or experience intolerable side effects.

Вмешательства

• Препарат BT02
  BT02 monoclonal antibody injection with intravenous administration every 2 or 3 weeks

Первичные конечные точки

• Adverse events [Срок оценки: Through the study completion, an average of 2.5 years]
• Dose limited toxicity(DLT) [Срок оценки: Through the dose escalation phase, an average of 10 months]
• Maximum tolerable dose(MTD) [Срок оценки: Through the dose escalation phase, an average of 10 months]
• Recommended phase 2 dose(RP2D) [Срок оценки: Through the study completion, an average of 2.5 years]

Вторичные конечные точки (8)

• Objective response rate (ORR) on tumor assessments [Срок оценки: Through the study completion, an average of 2.5 years]
• Progression-free survival (PFS) on tumor assessments [Срок оценки: Through the study completion, an average of 2.5 years]
• Overall survival (OS) [Срок оценки: Through the study completion, an average of 2.5 years]
• Duration of response (DoR) on tumor assessments [Срок оценки: Through the study completion, an average of 2.5 years]
• Disease control rate (DCR) on tumor assessments [Срок оценки: Through the study completion, an average of 2.5years]
• Mean and median Area under the curve (AUC) of BT02 following first dose and repeated administration at each dose level [Срок оценки: Through the study completion, an average of 2.5 years]
• Mean and median Maximum concentration (Cmax) of BT02 following first dose and repeated administration at each dose level [Срок оценки: Through the study completion, an average of 2.5 years]
• ADA and NAb incidence [Срок оценки: Through the study completion, an average of 2.5 years]

Критерии участия

Критерии включения

• Voluntary participation with signed informed consent by the participant or their legal guardian and being willing and able to comply with all trial procedures.
• Age:≥18 and <70 years, any gender.
• Diagnosis:Confirmed hematologic malignancy (leukemia, lymphoma, or multiple myeloma) .
• Leukemia-Specific Requirement:Bone marrow blast count ≥5% (morphological) at screening.
• Measurable Disease.
• Relapsed/Refractory Status.
• Adequate organ and hematologic function.
• An ECOG activity status score of 0-1.
• A life expectancy of ≥ 3 months.
• Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.

Критерии исключения

• Acute promyelocytic leukemia (APL).
• Patients with hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome.
• Patients with isolated extramedullary leukemia and multiple myeloma.
• Patients with uncontrolled active central nervous system leukemia (CNSL).
• Patients who have received anticancer therapy prior to administration.
• A history of active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years.
• A history of clinically significant cardiovascular disease, severe cardiac rhythm/conduction abnormalities ,severe pulmonary disease that may lead to severe episodes of dyspnea,head trauma, impaired consciousness, epilepsy, cerebral ischemia, or cerebral hemorrhagic disease.
• A severe acute or chronic infection when enrollment.
• Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
• Unresolved > grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.
• Patients undergoing acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD or systemic GVHD therapy.
• A history of other type of malignancies.
• Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
• Poor compliance.
• A history of alcohol/drugs abuse.
• Current pregnancy or breastfeeding.
• Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07107204 · BT02-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗