Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma

Официальное название

A Phase Ib/II Clinical Trial of Linperlisib Combined With Camrelizumab and Pegaspargase in Advanced or Relapsed/Refractory NK/T-cell Lymphoma

Обзор

The patients diagnosed with relapsed/refractory or advanced NK/T-cell Lymphoma (r/r NKTCL) were selected as the research objects. To explore effective and safe treatment for advanced or r/r NKTCL, the combination of PI3K-δ inhibitor Linperlisib with PD-1 blockade Camrelizumab and anti-metabolic agent Pegaspargase was applied for the treatment.

Подробное описание

This is a prospective, single-arm, single-center Ib/II clinical trial that included an initial safety run-in phase with safety monitoring before the main enrollment (expansion phase).The aim of phase Ib is to evaluate the recommended phase 2 dose and dose-limiting toxicity (DLT), and the aim of phase II study is to evaluate, for the first time, the safety and efficacy of the treatment of Linperlisib combined with PD-1 blockade Camrelizumab and Pegaspargase in patients diagnosed with advanced or r/r ENKTL, respectively.

Вмешательства

• Препарат Linperlisib
  Linperlisib: Phase Ib, oral, 80 mg/d, QD; Phase II, oral, RP2D, QD.
• Препарат Camrelizumab
  Camrelizumab for Injection: 200 mg/d, intravenous drip for 30 min (not less than 20 min and not more than 60 min), administered on day 1 of each cycle, observed for 2 hours after infusion. Every 3 weeks is a dosing cycle. Cycle 2 and subsequent cycles of dosing may be administered up to 5 days before or after the day of the scheduled dosing; more than 3 days after the date of the scheduled dosing will be considered a delayed dosing.
• Препарат Pegaspargase
  Pegaspargase: 2500 IU/m2, intramuscular injection, divided into three places, administered on the first day of each cycle, observed 2 hours after injection for the occurrence of anaphylactic reaction, if there is no anaphylactic reaction before giving other test drugs. Every 3 weeks as a dosing cycle. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.
• Препарат Dexamethasone
  Dexamethasone, 20 mg/d, days 1-4. Camrelizumab for Injection should not be applied on the same day as Dexamethasonee.

Первичные конечные точки

• The best objective response rate（ORR） over 6 treatment cycles [Срок оценки: Within 6 treatment cycles (each cycle is 21 days)]

Вторичные конечные точки (5)

• Objective Response Rate（ORR） [Срок оценки: At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days)]
• Complete Response （CR） [Срок оценки: At the end of 2nd, 4th, 6th treatment cycles,respectively (each cycle is 21 days)]
• Progression Free Survival (PFS) [Срок оценки: From date of enrollment until the date of progression or date of death from any cause, whichever came first, assesed up to 2 years.]
• Overall Survival (OS) [Срок оценки: From date of enrollment until the date of documented death from any cause or follow up, whichever came first, assesed up to 2 years.]
• Disease Control Rate（DCR） [Срок оценки: Up to 2 years after enrollment.]

Критерии участия

Критерии включения

• Histopathology and immunohistochemistry confirmed diagnosis of ENKTL according to WHO 2016 criteria.
• refractory or relapsed after initial remission, or Ann-Arbor stage III-IV de novo patients
• PET/CT or CT/MRI with at least one objectively evaluable lesion.
• Expected to survive more than 3 months.
• General status ECOG score 0-2 points.
• The laboratory test within 1 week before enrollment meets the following conditions:

Blood routine: WBC≥3×10e9/L, PLT≥75×10e9/L, ANC≥1.5×10e9/L. sCR≤1.5 mg/dL,GFR≥50 ml/min. Liver function: ALT \& AST≤3 times the upper limit of normal, TBIL ≤2 times the upper limit of normal.

Serum fibrinogen level≥1.0 g/L.

•Sign the informed consent form

Критерии исключения

• Patients with CNS involvement, or with other neoplasm;
• Patients has received PI3K inhibitor treatment before enrollment
• Poor performance status, ECOG≥2;
• Patients in lactation or pregnancy；
• Patients (male or female) have the possibility of childbirth but are unwilling or have not taken effective contraceptive measures；
• Patients allergic to any of the study drugs；
• Patients with active infection；
• Patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Patients with a history of interstitial pneumonia, non infectious pneumonia, or highly suspected interstitial pneumonia;
• Patients with a history of neurological or psychiatric disorders, including epilepsy or dementia, in the past
• According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect patient completion of the study.

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

• Liang Wang — Пекин

Идентификаторы

NCT: NCT06376721 · TREC2024-KY016

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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