A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Официальное название

An Open, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

Обзор

To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2D of GNC-038, or the MAD and DLT

Подробное описание

phase Ib: To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2Dof GNC-038, or the MAD and DLT of GNC-038 if MTD is not reached, by intravenous infusion (IV, QW) once a week (2 weeks as a cycle) phase II To explore the efficacy of GNC-038 in patients with relapsed or refractory non-Hodgkin's lymphoma

Вмешательства

• Препарат GNC-038
  Administration by intravenous infusion

Первичные конечные точки

• Dose limiting toxicity (DLT) [Срок оценки: Up to 14 days after the first dose]
• Maximum tolerated dose (MTD) or Maximum dose (MAD) [Срок оценки: Up to 14 days after the first dose]
• Adverse Events during Treatment (TEAE) [Срок оценки: Up to approximately 24 months]
• Recommended dose for Phase II clinical studies (RP2D) [Срок оценки: Up to 14 days after the first dose]

Вторичные конечные точки (10)

• disease control rate (DCR) [Срок оценки: Up to approximately 24 months]
• progression-free survival (PFS) [Срок оценки: Up to approximately 24 months]
• Adverse Events of Special Interest (AESI) [Срок оценки: Up to approximately 24 months]
• Cmax [Срок оценки: Up to approximately 24 months]
• Tmax [Срок оценки: Up to approximately 24 months]
• AUC0-INF [Срок оценки: Up to approximately 24 months]
• AUC0-T [Срок оценки: Up to approximately 24 months]
• T1/2 [Срок оценки: Up to approximately 24 months]
• anti-drug antibody (ADA) in Ⅰa [Срок оценки: Up to approximately 24 months]
• DOR (Duration of Response) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• The subject is capable of understanding the informed consent form, voluntarily participates, and signs the informed consent form;
• No gender restrictions;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Patients with histologically confirmed non-Hodgkin's lymphoma;
• Patients with relapsed or refractory non-Hodgkin's lymphoma (R/R NHL);
• Presence of measurable lesions during the screening period (lymph node lesions with any long diameter ≥1.5 cm or extranodal lesions with any long diameter >1.0 cm);
• ECOG performance status score ≤2;
• Adverse reactions from prior anti-tumor treatment have recovered to ≤Grade 1 as per CTCAE 5.0 criteria;
• Organ function levels meet the requirements before the first dose;
• Female subjects of childbearing potential or male subjects with partners of childbearing potential must use highly effective contraception from 7 days before the first dose until 12 weeks after treatment discontinuation. Female subjects of childbearing potential must have a negative serum/urine pregnancy test within 7 days before the first dose;
• The subject has the ability and willingness to comply with the study protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

Критерии исключения

• Pulmonary diseases classified as ≥Grade 3 according to NCI-CTCAE v5.0; patients currently diagnosed with interstitial lung disease (ILD);
• Active infections requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.;
• Active tuberculosis;
• Patients with active autoimmune diseases;
• History of other malignancies within 5 years prior to the first dose;
• HBsAg-positive and/or HBcAb-positive with HBV-DNA levels ≥ the lower limit of detection; HCV antibody-positive with HCV-RNA levels ≥ the lower limit of detection; HIV antibody-positive;
• Poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg);
• History of severe cardiovascular or cerebrovascular diseases;
• Patients with a history of hypersensitivity to recombinant humanized antibodies or any excipients of GNC-038;
• Pregnant or lactating women;
• Patients with central nervous system involvement;
• Major surgery within 28 days before the first dose of this study or planned major surgery during the study period;
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• Autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before initiating GNC-038 treatment;
• Current use of immunosuppressive therapy;
• Radiotherapy within 4 weeks before initiating GNC-038 treatment;
• Chemotherapy or small-molecule targeted therapy within 2 weeks or 5 half-lives prior to treatment;
• CAR-T therapy within 12 weeks before initiating GNC-038 treatment;
• Use of any other investigational drug in a clinical trial within 4 weeks or 5 half-lives before the first dose of this study;
• Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

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

Китай · 3 центра

• Beijing Cancer Hospital — Пекин
• Harbin First Hospital — Haerbin
• Qingdao Central Hospital — Qingdao

Идентификаторы

NCT: NCT05623982 · GNC-038-104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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